Biotis™ GOS Impacts Stool Frequency & Gut Microbiota

25/01/2022

A human trial that investigated if Biotis™ GOS impacts stool frequency in adults with constipation.

Constipation is one of the most common digestive problems, and a major issue for 10-20% of the global population.1,2 When we talk about constipation, we mean less than 3 defecations per week, dry and hard stool or difficulty in defecating.3 Constipation is more common in women than in men and its prevalence rises with age.4 Symptoms may be acute (less than a week) or chronic (for at least three months) and have a significant impact on daily living and well-being.5,6

Demand for (dietary) solutions to support digestive health complaints, such as constipation, isn’t new. And, with 26% of consumers unsatisfied with their digestive health,7 it’s a trend that is here to stay. At FrieslandCampina Ingredients, we’re responding by investing in the development and research of scientifically substantiated ingredients to help companies develop products that support the digestive comfort of adults.

This includes ingredients such as Biotis™ GOS which was the subject of exciting research on the impact of food on gut health. This well-controlled human trial showed the ability of Biotis™ GOS to increase stool frequency in the adult population with a low stool frequency.8

Want to know more? We’ve summarised the key findings of this study in this article!

But first, what is Biotis™ GOS?

Biotis™ GOS (galacto-oligosaccharides) is a dairy-derived prebiotic* ingredient. GOS have been shown to influence the composition and activity of the human gut microbiota9,10,11 and improve defecation frequency in older adults.12,13

What did the study aim to find out?

The intervention study was conducted by NIZO Food Research in close cooperation with FrieslandCampina Ingredients. It aimed to investigate whether the daily consumption of Biotis™ GOS influences stool characteristics and gut microbiota composition in the general adult population with constipation.

Who took part in the study?

132 healthy adults (94% female) aged 18-56 with self-reported constipation. Subjects were included in the study if they were healthy adults with a BMI between 18.5 and 28.0 kg/m2, with self-reported constipation according to the Rome IV criteria with fewer than three bowel movements per week and one or more of the following criteria: for at least 25% of all defecations: straining, lumpy or hard stools, sensation of incomplete evacuation, a sensation of anorectal obstructions/blockage, or manual manoeuvres.

What methods did the study use?

The study was designed as a double-blind randomised placebo-controlled clinical trial. Participants received either a daily dose of 5.5g of the prebiotic* Biotis™ GOS, 11g of Biotis™ GOS, or a placebo (maltodextrin) for 21 days.
Participants were instructed not to make any changes to their lifestyle, but to maintain their physical activity and habitual food and fluid intake during and 14 days before the study. All participants were requested to stop using medications for their constipation and (non-pharmaceutical) drugs during the study.

Participants were asked to fill in a daily diary to use as input for the weekly questionnaire in which information was recorded about stool frequency, consistency, quality of life, compliance to the study protocol and also changes in daily habits such as physical activity and dietary patterns. Furthermore, at the start and after the intervention, stool samples were taken to study fecal microbiota.

The following methods were used to measure the impact of Biotis™ GOS:

  • Validated questionnaires: Each week, participants completed the Constipation Scoring System, the Bristol Stool Chart, and the Patient Assessment of Constipation Symptoms questionnaire to assess the impact on stool frequency and consistency.
  • Microbiota analyses: Participants were provided with stool-sampling kits to self-collect feces for gut microbiota sequencing analysis.

What were the results of the study9?

As can be seen in the figure below, the study showed that 11g of Biotis™ GOS tends to increase stool frequency in adults with self-reported constipation. In reality, not all subjects had constipation (less than 3 stools per week) at the start of the study. In adults with a low stool frequency (≤3 stools per week), daily consumption of 11g of Biotis™ GOS significantly increased stool frequency. A subgroup analysis in which the participants were split based on younger adults and middle-aged adults showed that the effect on stool frequency was mainly present in the subjects aged 35 years or above.

Figure 1: Stool frequency (adapted from Schoemaker et al. Nutrients. 2022 Jan 12;14(2):309)

Daily consumption of 11g of Biotis™ GOS resulted in a higher number of initial responders (increase in stool frequency, with at least 1 bowel movement, in the first week compared to baseline) and consistent responders (increase in stool frequency in first and last intervention week) compared to placebo.

As can be seen in Figure 2, Biotis™ GOS intake also impacted the gut microbiota composition, showing a clear dose-response effect on fecal beneficial Bifidobacterium levels. The presence of Bifidobacteria in the gut has been correlated to gut homeostasis and a decreased number of Bifidobacterium species has been associated with antibiotic-associated diarrhea, IBS and IBD.14,15 Another interesting finding of this study is the significant stimulating effect of 11g of Biotis™ GOS on fecal Anaerostipes hadrus. This species has been associated with gut health.16,17

Figure 2: Bifidobacterium composition (%) (adapted from Schoemaker et al. Nutrients. 2022 Jan 12;14(2):309)

What do these findings mean for the nutrition and supplements industry?

Since the prevalence of gastro-intestinal (GI) discomfort is so widespread, and quality of life is strongly linked to a well-functioning GI tract, consumers are increasingly seeking natural, non-pharmaceutical solutions to support their gut health.

This study is very exciting because it is the first well-controlled human study that has used validated methods and has found a clinically relevant effect of GOS in the general adult population with low stool frequency.

These results add to the growing scientific substantiation about Biotis™ GOS that’s already available. Additionally, they suggest that a daily Biotis™ GOS supplement or fortified food and drink with Biotis™ GOS may be beneficial in instances of constipation.

You can read the full study here or download a PDF of this article.

*The scientific definition of a prebiotic is “A substrate that is selectively utilized by host microorganisms conferring a health benefit.” Gibson, GR., et al. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 2017 Aug;14(8): 491–502. Whether the claim prebiotic can be used on consumer products depends on local legislation.

References

  1. Rao, Rattanakovit & Patcharatrakul. Diagnosis and Management of Chronic Constipation in Adults. Nature Reviews Gastroenterology & Hepatology 2016, 13, 295–305
  2. Sperber et al. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. Gastroenterology 2021, 160, 99-114
  3. Serra et al. European Society of Neurogastroenterology and Motility Guidelines on Functional Constipation in Adults. Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society 2020, 32, e13762
  4. Higgins & Johanson. Epidemiology of Constipation in North America: A Systematic Review. The American journal of gastroenterology 2004, 99, 750–759
  5. Sanchez & Bercik. Epidemiology and Burden of Chronic Constipation. Canadian journal of gastroenterology = Journal canadien de gastroenterologie 2011, 25 Suppl B, 11B-15B
  6. Belsey et al. Systematic Review: Impact of Constipation on Quality of Life in Adults and Children. Alimentary pharmacology & therapeutics 2010, 31, 938–949
  7. FMCG Gurus Digestive health survey. October 2020. 20,000 respondents globally
  8. Schoemaker et al. Prebiotic Galacto-Oligosaccharides Impact Stool Frequency and Fecal Microbiota in Self-Reported Constipated Adults: A Randomized Clinical Trial. Nutrients 2022, 14, 309.
  9. Walton et al. A randomised crossover study investigating the effects of galacto-oligosaccharides on the faecal microbiota in men and women over 50 years of age. Br J Nutr. 2012 May;107(10):1466-75
  10. Krumbeck et al. Probiotic Bifidobacterium strains and galactooligosaccharides improve intestinal barrier function in obese adults but show no synergism when used together as synbiotics. Microbiome. 2018 Jun 28;6(1):121
  11. Johnstone et al. Anxiolytic effects of a galacto-oligosaccharides prebiotic in healthy females (18–25 years) with corresponding changes in gut bacterial composition. Sci Rep 11, 8302 (2021)
  12. Sairanen et al. Yoghurt containing galacto-oligosaccharides, prunes and linseed reduces the severity of mild constipation in elderly subjects. Eur J Clin Nutr. 2007 Dec;61(12):1423-8
  13. Teuri & Korpela. Galacto-Oligosaccharides Relieve Constipation in Elderly People. Annals of nutrition & metabolism 1998, 42, 319–27
  14. Grimm, V.; Westermann, C.; Riedel, C.U. Bifidobacteria-Host Interactions – An Update on Colonisation Factors. BioMed Research International 2014, 2014
  15. O’Callaghan & van Sinderen. Bifidobacteria and Their Role as Members of the Human Gut Microbiota. Frontiers in Microbiology 2016, 7
  16. Ai et al. Identifying Gut Microbiota Associated with Colorectal Cancer Using a Zero-Inflated Lognormal Model. Frontiers in Microbiology 2019, 10, 1–8
  17. Lyra et al. Diarrhoea-Predominant Irritable Bowel Syndrome Distinguishable by 16S RRNA Gene Phylotype Quantification. World Journal of Gastroenterology 2009, 15, 5936–5945
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