Abstract

Background: Breastfeeding is widely acknowledged as the preferred and recommended mode of infant nutrition. However, women who have undergone cesarean deliveries may face an increased risk of inadequate breast milk production, which can be addressed through various techniques, including the use of galactagogues, which stimulate breast milk production. Galactagogues are synthetic or plant molecules that induce, maintain, and increase milk production.

Method: In this current real-world evidence study, 53 lactating women were enrolled. During the study, they received lactobites bar for 28 days. The serum prolactin level of the mother, hours of the night and day sleep (of baby), intestinal health of the baby, incidences of formula feeding, number of breastfeeding per day, the volume of breast milk, baby's anthropometric measures: such as changes in weight, height, the weight of the mother, changes in quality of hair and skin of the mother were evaluated. The feeling of wellness in the mother and haemoglobin levels were also assessed during the study.

Results: The mothers who received lactobites bar showed significantly higher (13x) serumprolactin levels than the normal range in lactating mothers. Also, the haemoglobin levels weresignificantly increased in mothers who were given lactobites bar. A significant increase was observed in hours of night and day sleep, stool frequency per day, vol. of breast milk [baseline vs 28th day: 30.19 ± 34.4 vs 448.06 ± 651.11; P<0.05], no. of diapers per day, baby's weight [baseline vs 28th day: 2.91±0.35 vs 3.13±0.36; P<0.05] and height [baseline vs 28th day: 47.39±1.72 vs 50.1±1.62; P<0.05], changes in quality of hair and skin of mother, and the feeling of wellness in mother [baseline vs 28th day: 0.04 ± 0.19 vs 1.88 ± 0.32; P<0.05]. A significant reduction was observed in formula feeding incidence, no. of breastfeeding per day, and mother’s weight.

Conclusion: Lactobites bar can be used as a galactagogue to increase the human milk volumein lactating women.

Introduction & Background Information

Breastfeeding is widely acknowledged as the preferred and recommended mode of infant nutrition [1,2]. The prevalence of C-sections in India has increased from 8.5% to 17.2%, based on NFHS-4 data [3]. There are various factors which include health sector policies andfinancing, cultural norms, perceptions and practices, rates of preterm births, and quality ofhealthcare [4]. A diet rich in nutrients containing complex carbohydrates, fiber, healthy fats,and protein, along with sufficient hydration, has the potential to facilitate healing and expedite the body's recovery process. The composition of dietary intake plays a crucial role in determining both the quantity and quality of milk supply during lactation [5]. It is important to monitor specific nutrients such as iodine, Vitamins (B12), minerals, and omega-3 fatty acids, as they contribute to optimal recovery outcomes. Additionally, maintaining a wellbalanced diet, ensuring adequate rest and sleep, and sufficient water intake can support overall well-being. However, women who have undergone cesarean deliveries may face an increased risk of inadequate breast milk production, which can be addressed through varioustechniques like kangaroo mothering, relaxation techniques and the use of galactagogues,which stimulate breast milk production [1,2]. The Galactagogues are synthetic or plant molecules used to induce, maintain, and increase milk production, which mediate complex processes involving interaction between physical and physiological factors [6]. Among the most important factors are hormones such as prolactin (PRL). However, somatotropin, cortisol, insulin, leptin, estrogen, progesterone and medroxyprogesterone, oxytocin,recombinant bovine somatotropin (rBST), and thyrotropin-releasing hormone (TRH) also play an essential role as galactagogues. One such galactagogue is domperidone, which is commonly prescribed and has been shown to promote breast milk production in women with low milk supply. It has minimal transfer to maternal milk and does not significantly alter the nutrient composition [7–10]. The lactogenic effect of domperidone can be observed as early as two hours after ingestion, as measured by prolactin levels [11,12]. Other studies haveshown significant effects after 24 hours of treatment, as measured by prolactin levels and daily milk volume [13]. Despite no reported side effects in infants of mothers who have used domperidone, it is a controversial drug and has not been approved for marketing by the US FDA due to the potential increased risk of ventricular arrhythmia and sudden cardiac death in adults [2,14,15].Instead of pharmaceutical products, various complementary and alternative techniques canbe employed as galactagogues [16]. These include herbal medicines and techniques such asherbal compression, herbal supplements, herbal bars, and herbal teas that contain ginger,stinging nettle, fenugreek, or turmeric. These techniques have been shown to be effective inpromoting breast milk production without causing adverse effects [17–20].To combat low milk production during breastfeeding, several factors, including cesareandeliveries, have been linked to lactation difficulties [1,2,13]. Administering Domperidone topostpartum women who have undergone full-term cesarean has been found to enhance breast milk production [13]. Ginger is the most potent galactagogue ingredient at Wang Nam Yen Hospital, with evidence supporting its lactogenic effect as a single treatment within 48-72 hours of ingestion as measured by daily milk volume [20] and as a combined treatmentwith other herbs within 24 hours of ingestion as measured by prolactin level [19]. The WangNam Yen herbal tea, containing traditional Thai galactagogues such as ginger, lemon basil,and bottle gourd, may be a viable alternative to the commonly used pharmaceutical galactagogue, Domperidone, to address breastfeeding difficulties caused by low milk supply [18].

Lactobites bar

The bars are filled with energy-boosting ingredients like Dates, Berries - 8%, (Cranberry, Blueberry), Pea Protein, Seeds (Sesame, Pumpkin, Halim (Aaliv)), FOS, Oats, Almonds, Amarnath flour, Goond, Ghee, Honey, Coconut, Fennel powder, Spinach powder, Moringa leaves powder, Shatavari & Cinnamon Extract, Antioxidant (Vitamin E).

Fenugreek contains several flavonoids and vitamins which are beneficial for lactating mothers. It also contains phytoestrogen, like the female hormone estrogen, which stimulates the breast milk ducts to grow. Fenugreek contains a compound called diosgenin, which increases milk flow in lactating women. Reports of several clinical trends involving Fenugreek were reported by [21] to increase milk supply. A randomised, double-blind, placebocontrolled trial was described in Turkey. In this study, the fenugreek groups increased their milk supply, and their babies gained more weight than the placebo (apple juice) and controlgroups. No side effects were reported [22]. Fennel seeds contain volatile oil mainly composed of anethole, a phytoestrogen – a substance found in certain plants that can produce effects like the hormone estrogen when ingested into the body. Fennel powder can be used as a very potent laxative. It aids in milk volume, fat content and infant weight gain with fennelgalactagogues therapy. It has been used as a galactagogue in humans, and no adverse effectshave been reported yet [23,24]. It has been reported to increase milk secretion, improve reproductive cyclicity, facilitate birth, and increase libido [25].

Asparagus racemosus Wild. (Shatavari) is an anti inflammatory, boosts immunity, and helps increase prolactin level [26]. It also contains compounds that act as antidepressants. Thus, it can prevent postpartum blues or depression that often affects nursing mothers. Moringa canact as a galactagogue, a natural substance to support lactation, for postpartum mothers andeven mothers of preterm babies [27]. Moringa leaves are known to increase breast milk volume and infant weight gain and even support a baby’s sleep duration. Gondh (edible gum) boosts immunity, stamina and health. It is most popularly known to treat weakness. Pregnant and lactating women need that extra nutritional boost. Garden cress seeds (halim seeds) are very high in Iron and Folic acid content. These seeds are used as herbal medicine to treat iron deficiency/anaemia. It is also seen that cress seeds have anti-hypertensive properties. It hasdiuretic properties, due to which it has blood pressure lowering properties. In a preclinical study, garden cress seeds exhibited a strong mammotrophic and lactogenic effect [28,29].Berries (blueberry and cranberry)-The stand-out benefit of blueberries is their antioxidantproperties. Blueberries have the highest potency of antioxidants of any fruit [30,31]. Through papers published in the past, it has been confirmed that antioxidants do indeed pass through to the baby, which may help prevent disease in infancy. Cranberry (Vaccinium macrocarpon) fruit contains phenolics, flavonoids, anthocyanidins, and ellagitannins. It is most often used for the prevention of urinary tract infections [32]. Cinnamon helps to increase the flow of mother's milk. It will also help in delaying periods after childbirth. Datescontain high proportions of tryptophan, leading to an increase in prolactin. Prolactin is the hormone that tells the body to make breast milk when a person is pregnant or breastfeeding [33]. Dates have also been shown to contain antioxidant and antimutagenic properties. It also acts as a tonic to strengthen uterine muscles, and it may also promote brain health [34]. Turmeric possesses lipopolysaccharide, which strengthens the body’s immunity. The herb contains antifungal, antibacterial, and antiviral properties that help enhance immunity and protect from cough, cold, and the flu while nursing the baby. Turmeric, while breastfeeding, helps minimise breast inflammation and helps them to feed their baby properly [35,36]. Compared with other vegetables, fresh spinach contains a good amount of iron, with a 100-gram serving of fresh spinach providing 2.7 milligrams of this important mineral. Spinachpowder is an excellent source of fiber and dehydration preserves the full dietary fiber content of spinach [37,38]. Almonds are a storehouse of essential nutrients like Vitamin E, Vitamin B2, B3, and B1. It is also a rich source of minerals like Magnesium, Copper, Phosphorus, Calcium, Iron, and Zinc [39]. Oats help to stay calm by releasing oxytocin and relaxin which stimulates the milk production process and helps with flow. Oats have presence of nutrients such as beta-glucans, protein, fiber, carbohydrates, etc., that are responsible for healthier lusher milk supply [40]. Ginger effectively enhances breast milk production rate. The elementsor the ketones present in ginger boosts the immune system and reduce conditions of inflammation [36]. Honey has high levels of fructose and glucose, which provide stamina and energy. It has anti-bacterial, anti-fungal and antioxidant properties that boost the immunesystem [41]. Pumpkin seeds, or pepitas, are a rich source of iron, protein and fiber. Iron isessential for proper nerve cell development and the specialisation of certain brain cells. Pumpkin seeds provide omega 3 fatty acids those are important for baby’s nerves and brain development It is also a natural source of DHA and alpha linolenic acid which help nursingmoms in breastfeeding supply [6].

Herbal galactagogues are increasingly used as alternative therapies to enhance breast milkproduction. Some studies show that herbal galactagogues can increase breast milk production. The attitude of breastfeeding women toward herbal galactagogues was quitepositive as the chances of side effects were less compared to that of synthetically produceddrugs. The objective of this study was to evaluate the effect of Lactobites bar as a galactagogue to increase the production of milk in lactating women and metabolism boosting effect which can contribute to weight loss and fat burn.

Materials and Methods

Ethics statement

The Suraksha Institutional Ethics Committee approved the study protocol and related materials in compliance with ICMR (Indian Council of Medical Research), New Drugs and Clinical Trials Rules, 2019, ICH GCP, and the declaration of Helsinki.

Study design and patients

This study was a post marketing Phase IV study.
The goal of the study was to evaluate the effect of Lactobites bar (Nutrizoe Nutriifoods) as agalactagogue to increase the production of milk in lactating women as well as to providenutrition for postpartum recovery. Study sites obtained approval from local independentethics committees, and each patient signed informed consent before participating in the trial.The study included lactating women between 23 and 45 years old who have given birth to ahealthy baby at term (born between 37 and 42 weeks) and those who have the perception ofhaving a little volume of milk or nutritional composition of milk that is not adequate for theirbaby, women with 2 weeks of breastfeeding, and that at the time of beginning the study, theyare not supplementing with formula milk for feeding their baby, they have the firm intentionof breastfeeding for 28 more days.The study excluded participants suffering from any disease that may hinder or prevent breastfeeding, being currently consuming or having consumed in the two weeks prior to thestudy a probiotic or a supplement with plant extracts, being consuming any drug that canalter the volume or composition of breast milk, have an allergy to any antibiotics or peanuts,have an allergy to any of the components of the products under study.

Study intervention

Lactobite bar was administered as 1 - 2 bars daily for 28 days.

Outcome measures

The primary outcome measure involved were serum levels of prolactin and haemoglobin of the mother.

The secondary outcome measure involved sleep parameters of the baby: hours of the night sleeping per day and hours of total sleeping during the day, intestinal health of the baby, incidences of formula feeding, number of breastfeeding per day, the volume of the breast milk, baby's anthropometric measures: such as changes in weight, height & BMI, the weight of the mother, changes in quality of hair and skin of the mother, and feeling of wellness in mother.

Results:

Figure 1: Table of evaluation parameters

A total of 53 lactating women were recruited during the study. The average age of the subject was 30.72 years. Allergic contact dermatitis, antibiotic resistance, and anaphylaxis was not observed in any patient. All the patients completing the study reported no bothersome side effects during the study period. Since observations are quantitative, paired t-test was carried out to test significance in parameter pre and post study. From the above table, we can observe that P-Value is less than 0.05.

A significant increase was observed in hours of night and day sleep, stool frequency per day, vol. of breast milk, no. of diapers per day, baby's weight and height, changes in quality of hair and skin of mother, the feeling of wellness in mother, and in haemoglobin levels (figure 1,table 1).

A significant reduction was observed in formula feeding incidence, no. of breast feeding per day, mother’s weight. There were no significant changes in serum prolactin levels, it remained higher than the normal range in the lactating mothers. (figure 1, table 1).

Discussion:

The current post marketing phase IV study was conducted to evaluate the effect of the Lactobites bar as a galactagogue to increase the production of milk in lactating women. Study result revealed that lactobites bar showed significant increase in hours of night and day sleep,stool frequency per day, vol. of breast milk, no. of diapers per day, baby's weight and height,changes in quality of hair and skin of mother and feeling of wellness in mother and in haemoglobin levels. There was a significant reduction observed in formula feeding incidence,no. of breastfeeding per day, mother’s weight. There was no significant change in serumprolactin levels, but it remained significantly higher than the normal range in lactating mothers. There were no serious side effects observed, and it is safe for both mother and the baby.

Prolactin is a polypeptide hormone formed mainly by lactotroph cells (in the anterior pituitary gland) [42]. Maternal prolactin level is influenced by the rise of oestrogen and progesterone thus it increases and reaches five to ten times its level in non-pregnancy state [43]. In normal pregnancy, the rise of maternal prolactin occurs gradually from 10-20 ng/ml (pre pregnancy level) to 200-400 ng/ml at term. If the prolactin levels are too low, a mother will not be able to produce milk, and if the levels are inappropriately elevated, this can lead to galactorrhea in non-breastfeeding females or males [43]. Prolactin contributes to hundreds of physiologic functions including regulation of immune system, but the two primary responsibilities aremilk production and the development of mammary glands within breast tissues [42]. Thus the mothers taking lactobites bar have seen an increased prolactin levels than the normal, whichhelps in increased milk production. Anemia is one of the most frequent complications related to pregnancy [44]. Many women lack the sufficient amount of iron needed for the second and third trimesters. When the body needs more iron than it has available, one can becomeanemic [44]. Anemia with hemoglobin levels less than 6 g/dl is associated with poorpregnancy outcome. Mild anemia is normal during pregnancy due to an increase in blood volume. More severe anemia, however, can put the baby at higher risk for anemia later in infancy. An Hb level of 11 g/dl in the late first trimester and also of 10 g/dl in the second and third trimesters are suggested as lower limits for Hb concentration [45]. Our study has shown that lactobites bar aids increasing the heamoglobin levels. Also, based on the above results, we can infer that the lactobites bar are safe for mothers as they don’t cause any serious side effects and also they are safe for baby as it can be observed from the stool frequency, consistency. The lactobites bar are also filling for the baby as the change in number of diaper is quite frequent compared to baseline, this shows that the babies are drinking milk frequently this is confirmed from the data where the volume of milk has shown significant increase in mothers who received lactobites bar.

In a previous study, a herbal tea consisting of fennel and fenugreek seed was administered to lactating mothers, and similar results were observed which showed improved signs of breastmilk sufficiency [46]. In another study, a randomized double-blind controlled trial the effects of fenugreek, ginger, and turmeric supplementation was evaluated on breastfeeding mothers and the results showed an increased human milk volume without adverse effects [36].

Conclusion:

In conclusion, this real world evidence study demonstrated a significant increase in vol. of breast milk, no. of breastfeeding per day, baby's weight and height, babies hours of night and day sleep, stool frequency per day, and no. of diapers per day. It showed a significant reduction in formula feeding incidence. It showed an overall wellness of mothers by supporting recovery at the postpartum stage.

Abbreviations:

ICMR - Indian Council of Medical Research

ICH - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

GCP - Guideline for Good Clinical Practice

BMI - Body Mass Index

SD - Standard Deviation

Acknowledgement:

Authors thank Nirav Bhatia from Intellimed Healthcare Solutions LLP, Mumbai for medical writing support.

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