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Probiotics and Microbiota in Bariatric Surgery

NCT01922830 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-07-19

No results posted yet for this study

Summary

This study is a randomized clinical trial with 6 months probiotic supplement vs. placebo treatment and 6 month follow up on 100 NAFLD patients that will undergo sleeve gastrectomy surgery. Measurements will be conducted at: baseline, M3 (3 months after treatment initiation), M6 and M12 and will include: abdominal US, Fibroscan, biochemical tests, anthropometric measurements, glucose breath test for bacterial overgrowth, fecal samples and questionnaires for demographic details, quality of life, food intake, food tolerance and habitual physical activity. 20 subjects will undergo an additional liver-MRI test at baseline and M6.

Additionally, 30 healthy participants will consume probiotic supplement vs. placebo for 28 days and will undergo gastroscopy and colonoscopy before and during consumption.

Conditions

  • NAFLD

Interventions

DIETARY_SUPPLEMENT

Bio-25 (Supherb)

The Bio-25 (Supherb) is a probiotic supplement consisting of 11 different species of patented probiotic bacteria and over 25 billion active bacteria in each capsule. The bacteria in the formula are patented bacteria that have undergone drying, freezing, and double coating which ensures their survival under stomach acidity conditions and their enrooting in the intestines.

DIETARY_SUPPLEMENT

Placebo (for Bio-25, Supherb)

A pill manufactured to mimic Bio-25 (Supherb) pill

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Oren Shibolet, MD · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Israel

Study Locations

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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 NCT01922830 on ClinicalTrials.gov