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Effect of Probiotic Administration on Gut Flora Composition

NCT03330678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-11-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-11-30
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03330678 on ClinicalTrials.gov