Effect of Probiotic Administration on Gut Flora Composition

NCT03330678 | Completed

• 1 other identifier: 2012-70-EMP-61
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

Healthy human gut contains a large number of bacteria, which belong to several different species. Some genes in these bacteria encode enzymes that the human body cannot produce. These enzymes can catalyze metabolic reactions in the distal small bowel. For instance, bacterial enzymes can breakdown indigestible dietary constituents, making available extra energy to the host. The current paradigm treats the human body as a 'metagenome', i.e. a composite of Homo sapiens genes and genes in the genomes of the colonizing bacteria. Till recently, accurate determination of bacterial gut flora was not possible. Recent development of multi-parallel sequencing techniques has allowed unbiased determination of profile of gut flora. These techniques have revealed changes in gut flora in several disease conditions, including those of the gastrointestinal tract and liver. This has prompted the use of drugs, such as probiotics to restore the gut flora. Probiotics contain living microorganisms, and are administered in an attempt to obtain health benefits by restoring normal gut flora. These preparations provide benefit to patients with several diseases, including childhood diarrhea, antibiotic-associated diarrhea, inflammatory bowel disease, vaginitis, etc. However, the mechanisms of their beneficial effects remains unclear. Gut microbiota appear to modulate the development of immune system and maintain a balance between Th17 and T regulatory cells in animals. However, it is not known whether administration of probiotics changes the profile (nature and relative density of various species) of gut flora, and whether these changes are short-lasted or persistent. This proposal aimed to study whether probiotic administration influences the gut bacterial profile and host immune responses. In addition, we wished to determine whether the changes in gut flora and immune responses persist after probiotic administration is stopped.

Conditions

Probiotics

Keywords

Probiotic; Gut microbiome; VSL#3

Outcome Measures

Primary Outcomes (3)

• Profile of gut flora among healthy Indian women

  To determine the profile of gut flora (% abundance of various bacterial phyla, families, genera and species) in healthy Indian women, using a metagenomic technique (sequencing of V3 region of 16S ribosomal RNA).

  Baseline

• Effect of probiotic preparation on gut-flora profile

  To determine the effect of administration of a probiotic preparation for a 4-week period on the profile of gut flora in healthy Indian women.

  4 weeks of probiotics administration

• Effect of probiotic on immune responses

  To assess the effect of probiotic administration on immune responses, and the persistence of such changes on discontinuation of probiotic administration

  4 weeks of probiotics administration

Secondary Outcomes (1)

• Persistence of changes, if any, in gut flora after probiotic discontinuation

  4 weeks of discontinuation of probiotics administration

Study Arms (1)

Probiotic (VSL#3)

EXPERIMENTAL

Probiotics will be given to women included in study arm

Dietary Supplement: Probiotic (VSL#3)

Interventions

Probiotic (VSL#3) DIETARY_SUPPLEMENT

Each subject provided morning stool and venous blood ubes) specimens at three time-points, i.e. at baseline (before probiotic administration), after probiotic administration (VSL#3®, one capsule twice a day) for 4 weeks, and at 4 weeks after stopping the probiotic intake. Each capsule contained approximately 112.5 billion live freeze-dried bacteria (a mixture of eight species -- Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, and Lactobacillus delbrueckii), which had been stored at 2-4ºC till ingestion.

Probiotic (VSL#3)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Study was planned to study in women only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy
• non-pregnant women

You may not qualify if:

• (i) a systemic (diabetes, autoimmune disease, cancer), gastrointestinal or liver disease that is known to be associated with alteration in intestinal microbiota, (ii) obesity or malnutrition (body mass index of \<18.5 or \>25 Kg/m2), (iii) history of taking an anti-microbial agent, probiotic, or a drug that suppresses gastric acid or alters gastrointestinal motility, in the previous 6 weeks, (iv) any inter-current illness in the last 8 weeks, or (v) a recent change in dietary or bowel habits

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead
• Indian Council of Medical Research: collaborator

Related Publications (1)

• Singh A, Sarangi AN, Goel A, Srivastava R, Bhargava R, Gaur P, Aggarwal A, Aggarwal R. Effect of administration of a probiotic preparation on gut microbiota and immune response in healthy women in India: an open-label, single-arm pilot study. BMC Gastroenterol. 2018 Jun 15;18(1):85. doi: 10.1186/s12876-018-0819-6.

  PMID: 29907093 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Model Details: Healthy young women will be given VSL#3 for 4 weeks

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 6, 2017
• Study Start: December 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share