Functional gastro-intestinal disorders (FGIDs) occur in more than 25% of infants, with regurgitation, infantile colic and functional constipation being the most common types. They have no identifiable underlying organic cause but are a frequent reason for hospitalisation, parental anxiety, and administration of drugs.
Parents often expect the health care provider to deliver a prescription and this has led to increasing prescriptions of proton pump inhibitors and other medications. The aim of this open real-life observational intervention study was to evaluate, in infants presenting with a least two FGIDs, the efficacy of an infant formula containing five key components: hydrolysate, starch, high magnesium content, prebiotic fructo-oligosaccharide and galacto-oligosaccharide and the probiotic Lactobacillus reuteri DSM 17938.
The study was funded by Nestlé Nutrition Institute and conducted by a researcher from the institute in partnership with a team from Vrije Universiteit Brussel, Belgium.
The study was a prospective, multicenter, observational study over 14 days in full formula-fed 0–4 months old infants presenting with at least two FGIDs.
The efficacy of the formula was evaluated with the Cow Milk-associated Symptom Score (CoMiSS) and quality of life with the QUALIN score.
The primary outcome, the CoMiSS, showed a statistically significant decrease as soon as Day 3 onwards, which was confirmed at Day 7 and 14. The mean decrease of baseline CoMiSS was 34%.
The authors conclude: "This open interventional trial with a new therapeutic 'comfort' formula containing pHF-W, GOS and FOS, the probiotic L reuteri DSM 17938, a high content of magnesium and starch was shown to decrease infant crying, regurgitation and constipation within three days (according to CoMiSS), subsequently increasing quality of life (according to QUALIN score). The rapid improvement of FGIDs in infants in these real-world study conditions is key in the management of FGIDs since improvement of symptoms will reassure parents...
"A real-life observational study cannot exclude a placebo effect of the dietary intervention, but most important is that symptoms decreased and QoL improved. Since nutritional treatment is safe, it offers the possibility to health care providers to improve the QoL of families with infants with FGIDs without risk of adverse effects."
RCTs have previously shown efficacy for each of the specific ingredients in the studied formula. FOS and GOS are well-studied prebiotics in infant feeding known to stimulate the growth of lactobacilli and bifidobacteria and to decrease possible pathogens in the GI microbiome.
There is evidence from RCTs that a formula with FOS and GOS, a pHF-W and starch is effective in the management of constipation and colic. Defecation frequency in infants fed a pHF-W is almost twice the frequency of infants fed intact protein. The prebiotic scGOS/lcFOS formulas have positive effects on stool characteristics such as stool consistency and stool frequency. The probiotic added to the test formula, L. reuteri DSM 17938, has also been shown to be effective in the management of colic.
Magnesium-rich formula was previously shown to be effective in the management of infant constipation. Compounds such as magnesium citrate work by pulling water into the intestines and decreasing the hardness of stools. An open trial with a pHF-W, GOS, Bifidobacterium lactis and high magnesium was previously reported to be effective in the management of constipation and improved many QoL aspects, such as sleep and work-related QoL, parent–child relationship, better social interaction, resulting in a daily and overall improved QoL.
The test formula in this study has a reduced lactose content (5.0 g/100 mL). Lactose is an important carbohydrate as it is the predominant carbohydrate in mother’s milk, which enhances the development of a GI microbiome rich in lactobacilli and bifidobacteria and lactose in infant formula improves calcium absorption. However, a formula without lactose content has been shown to result in a clinically significant decrease of FGIDs. Therefore, the authors suggest a reduced content of lactose may offer the balance between advantages and disadvantages of lactose.
Vandenplas, Y.; Gerlier, L.; Caekelbergh, K.; Nan-Study-Group; Possner, M.
"An Observational Real-Life Study with a New Infant Formula in Infants with Functional Gastro-Intestinal Disorders"