Status:
COMPLETED
Effect of Probiotic Administration on Gut Flora Composition
Lead Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Collaborating Sponsors:
Indian Council of Medical Research
Conditions:
Probiotics
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 cata...
Detailed Description
Study Subjects The study included 14 healthy non-pregnant women. All subjects provided a written informed consent. The subjects had to (i) be free of systemic (diabetes, autoimmune disease, cancer), g...
Eligibility Criteria
Inclusion
- healthy
- non-pregnant women
Exclusion
- (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
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03330678
Start Date
December 1 2013
End Date
December 1 2015
Last Update
November 6 2017
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