Gastrointestinal Health / FGIDs

Clinically proven innovations for FGID management

With the conviction that nutritional measures should be the first line in management, Danone Nutricia Research has pioneered innovative formulas with clinically proven efficacies, for non-breastfed infants.

More than 40 years of research in GI health.

We continuously collaborate with global experts to provide healthcare professionals with evidence-based nutritional solutions in an integrated approach for a range of GI issues.

Our innovations have been shown to elicit clinically meaningful improvements for infants suffering from FGIDs.

Nutricia Comfort

Digestive discomfort in infancy includes infantile colic, constipation, regurgitation and other symptoms such as flatulence. For the dietary management of GI symptoms Nutricia Research has introduced its first Comfort infant formula since 2000.

The formula contains a blend of partially hydrolysed whey protein, a unique fat blend with β-palmitic acid, prebiotic mixture scGOS/lcFOS (9:1), starch and reduced lactose.

Partially hydrolysed whey protein
The protein in the Comfort formulation is partially broken down into peptides (pre-digested), which can be easier to be digested1Billeaud C. et al. Eur J Clin Nutr. Published on 1990;44:577-83 ,2Tolia V, et al. J Pediatr Gastroenterol Nutr. Published on 1992;15:297-301 and leads to softer stools compared to cow’s milk-based formulas with intact protein.3Mihatsch WA and Pohlandt F. Pediatr Res, Published on 1997;42:410

Fat blend with β-palmitic acid
Inspired by human milk, this fat blend mimics the specific structure of human milk fat.  Dietary fats are mostly triglycerides, consisting three fatty acids attached to a glycerol molecule. In standard infant formulas, which mainly comprise α-palmitic acid (i.e. palmitic acid is α-positioned in the glycerol molecule), enzyme splits the triglyceride mainly at the α-position and leads to two free palmitic acids and one monoglyceride (figure a).4Carnielli, VP et al. J Pediatr Gastroenterol Nutr. Published on 1996;23:553-60 In the presence of calcium, free palmitic acid subsequently forms so-called calcium soaps, which are insoluble and thus contribute to hard stool. If palmitic acid is β-positioned in the glycerol molecule (figure b).5Carnielli, VP et al. J Pediatr Gastroenterol Nutr. Published on 1996;23:553-60 lipase cannot split palmitic acid from glycerol. As a consequence, less calcium soaps will be formed (thus less hard stools), β-palmitic acid and calcium will be absorbed by the intestine.

Partnering with Unilever, we pioneered the research on β-palmitic acid in 1990s.6Havlicekova et al. Nutr J, Published on 2016;15:28

In 1995, we were the first to introduce formula containing β-palmitic acid.

Prebiotic mixture scGOS/lcFOS (9:1).
Our patented prebiotic mixture mimics the prebiotic effect of human milk oligosaccharides. This mixture of over 100 oligosaccharides consists of short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides in a 9:1 ratio – a composition that closely mimics the complexity, diversity, amount and functionality of HMOS in human milk and has shown its clinical benefits.

scGOS/lcFOS (9:1) is not digested by human enzymes and thus available as substrates for the gut microbiota. The beneficial effects of this unique prebiotic mixture include the promotion of healthy gut conditions by stimulating the growth of beneficial bacteria and discouraging the growth of pathogens; and improved stool characteristics (softer and frequent stools).

Starch.
Slightly thickened formula with starch can support a controlled, even intake of feed, thus helping to reduce the regurgitation/posseting associated with a rapid formula intake.7Horvath D, et al. Pediatrics, Published on 2008;122:e1268-77

Reduced lactose.
Lactose is reduced to minimise the anaerobic fermentation of indigested lactose in the gut. Since colic may be due to a mild form of incomplete lactose digestion, reduced lactose in the formula can help to reduce flatulence and digestive discomfort.8Harms HK and Hecker WC. Gustav Fischer Verlag, Published on 1988 Stuttgart; 285-373

Our Comfort formula has been investigated in numerous clinical studies. With its unique and innovative components, it has been shown to improve symptoms of digestive discomfort such as infantile colic, constipation, regurgitation/posseting. 

Nutricia AR (anti-regurgitation)

The North American and European Societies for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN/ESPGHAN) has defined infant regurgitation and reflux (Rosen et al. 2018):

Infant regurgitation:
  • passage of gastric contents into the pharynx and expelled out of the mouth.
Gastroesophageal reflux (GER):
  • passage of gastric contents into the esophagus with or without regurgitation and vomiting.

Regurgitation is caused by the immaturity of the oesophageal sphincter, which is a valve mechanism that stops stomach contents from going back up into the oesophagus see figure below).9Lightdale JR and Gremse DA. Pediatrics, Published on 2013;131:e1684-95

The main goal of management is to provide effective parental reassurance and symptom relief.10Benninga MA, et al. Gastroenterology. Published on 2016;150:1443–1455

Anti-regurgitation formula can decrease regurgitation.

The nutritional management of regurgitation consists of correcting the frequency and volume of feeds. For non-breastfed infants, thickened formula or anti-regurgitation (AR) formula can decrease regurgitation.11Horvath D, et al. Pediatrics, Published on 2008;122:e1268-77 ,12Vandenplas Y, J of Pediatr Gastroenterol Nutr. Published on 2009;49:498–547

There are several different ways to thicken infant formula. The most common ingredients are carob-bean gum, corn starch, rice starch, cereal, and soy fibres. In a review of 14 controlled studies evaluating the efficacy of these different thickeners, carob-bean gum was effective in reducing both the number of infants with regurgitation and the number of episodes of regurgitation.13Horvath D, et al. Pediatrics, Published on 2008;122:e1268-77

In our laboratory study, AR formulas supplemented with starch showed a strong loss in viscosity after the addition of saliva and stomach juice. In contrast, the viscosity of Nutricia AR containing carob-bean gum remained high after the addition of saliva and during stomach digestion.

Read more on: Gut and Microbiology – Our technologies

Since higher viscosity is linked to lower likeliness of the stomach contents moving back up into the oesophagus, these in vitro data demonstrate the superiority of the AR formula supplemented with carob-bean gum.

The integrated safety review of the toxicological database and clinical evidence concluded that carob-bean gum is safe for its intended therapeutic use in term-born infants to treat uncomplicated regurgitation from birth onwards.14Meunier L, et al. Regul Toxicol Pharmacol,  Published on 2014;70(1):155-69

Our first AR formula was developed in 1992.

 Carob bean gum

Carob-bean gum is a low-calorie, non-glycaemic thickening agent. Carob-bean gum thickens the feed and prevents stomach content to reduce regurgitation. Carob-bean gum is also less affected by saliva α-amylase (as compared to starch) and retains its viscosity in the stomach for greater feed retention.

Since 1992, five randomized clinical trials have been conducted to prove its efficacy in managing regurgitation and reflux.

scGOS/lcFOS (9:1)

Besides thickened with carob-bean gum (0.4 g/100 ml), the AR formula is supplemented with scGOS/lcFOS (9:1).

This prebiotic mixture mimics the prebiotic effect of human milk oligosaccharides. This mixture of over 100 oligosaccharides consists of short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides in a 9:1 ratio – a composition that closely mimics the complexity, diversity, amount and functionality of HMOS in human milk and has shown its clinical benefits.

Click here to read more: The impact of early life nutrition on immunity through gut

Postbiotics

To harness these potential benefits for the developing infant, learning from the benefits of human milk seen in breastfed infants, postbiotics are now used in AR, in addition to Carob-bean gum and the prebiotic mixture.

Postbiotics are bioactive compounds produced by food-grade micro-organisms during a fermentation process.

Research shows that formulae fermented with two particular bacterial strains – Bifidobacterium breve C50 and Streptococcus thermophilus 065 with an unique fermentation process Lactofidus™ – has a range of advantages for infants, in comparison with formulas lacking postbiotics. The scientific evidence therefore supports the addition of postbiotics to formulae to confer a wide range of  benefits for the developing infant including immune and gastro intestinal health.

Click here to read more: The impact of early life nutrition on immunity through gut

Nutricia AR, uniquely composed with Carob-bean gum, prebiotics scGOS/lcFOS (9:1) and postbiotics, for the management of regurgitation and reflux by improving gut microbiota composition and stool characteristics

View References

View References
1 Billeaud C. et al. Eur J Clin Nutr. Published on 1990;44:577-83
2 Tolia V, et al. J Pediatr Gastroenterol Nutr. Published on 1992;15:297-301
3 Mihatsch WA and Pohlandt F. Pediatr Res, Published on 1997;42:410
4, 5 Carnielli, VP et al. J Pediatr Gastroenterol Nutr. Published on 1996;23:553-60
6 Havlicekova et al. Nutr J, Published on 2016;15:28
7, 11, 13 Horvath D, et al. Pediatrics, Published on 2008;122:e1268-77
8 Harms HK and Hecker WC. Gustav Fischer Verlag, Published on 1988 Stuttgart; 285-373
9 Lightdale JR and Gremse DA. Pediatrics, Published on 2013;131:e1684-95
10 Benninga MA, et al. Gastroenterology. Published on 2016;150:1443–1455
12 Vandenplas Y, J of Pediatr Gastroenterol Nutr. Published on 2009;49:498–547
14 Meunier L, et al. Regul Toxicol Pharmacol,  Published on 2014;70(1):155-69