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Effect of Probiotic Administration on Gut Flora Composition

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ClinicalTrials.gov Identifier: NCT03330678
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Rakesh Aggarwal, Sanjay Gandhi Postgraduate Institute of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Probiotics Dietary Supplement: Probiotic (VSL#3) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Healthy young women will be given VSL#3 for 4 weeks
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Change in Human Gut Flora and in Immune Functions Following Probiotic Administration
Actual Study Start Date : December 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Probiotic (VSL#3)
Probiotics will be given to women included in study arm
Dietary Supplement: Probiotic (VSL#3)
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.




Primary Outcome Measures :
  1. Profile of gut flora among healthy Indian women [ Time Frame: Baseline ]
    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).

  2. Effect of probiotic preparation on gut-flora profile [ Time Frame: 4 weeks of probiotics administration ]
    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.

  3. Effect of probiotic on immune responses [ Time Frame: 4 weeks of probiotics administration ]
    To assess the effect of probiotic administration on immune responses, and the persistence of such changes on discontinuation of probiotic administration


Secondary Outcome Measures :
  1. Persistence of changes, if any, in gut flora after probiotic discontinuation [ Time Frame: 4 weeks of discontinuation of probiotics administration ]
    To determine whether the changes in gut flora after probiotic administration persist after discontinuation of such administration (at 4 weeks after such discontinuation)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study was planned to study in women only
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy
  • non-pregnant women

Exclusion Criteria:

(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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rakesh Aggarwal, Professor, Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT03330678     History of Changes
Other Study ID Numbers: 2012-70-EMP-61
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not have any such plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Rakesh Aggarwal, Sanjay Gandhi Postgraduate Institute of Medical Sciences:
Probiotic
Gut microbiome
VSL#3