Probiotics and Microbiota in Bariatric Surgery

NCT01922830 | Unknown

• 1 other identifier: TASMC-13-OS-196-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sleeve Gastrectomy; NAFLD; gut microbiot; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Hepato-Renal Index (HRI) method by abdominal US

  US will be performed at pretrial, 6 ,12 , 36 months after the surgery. .Fatty liver will be diagnosed by abdominal US using standardized criteria. HRI, a validated quantitative measure, will be calculated on the basis of the ratio between the echogenicity of the liver and that of the right kidney cortex using histogram echo intensity.

  36 months

Secondary Outcomes (9)

• Liver fibrosis - by Fibroscan (transient elastography)

  36 months

• Anthropometric measurements

  36 months

• Biochemical fasting blood tests

  36 months

• The fecal microbiota composition

  6 years

• Quality of life (QoL)

  36 months

Study Arms (2)

Bio-25 (Supherb)

EXPERIMENTAL

Bio-25 (Supherb) once daily (2 capsules -50 billion bacteria) for 6 months (or 4 weeks for healthy participants). 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: Bio-25 (Supherb)

Placebo

PLACEBO COMPARATOR

Identical placebo once daily (2 capsules) for 6 months (or 4 weeks for healthy participants). The placebo supplementation is identical-looking to the Bio-25 supplement.

Dietary Supplement: Placebo (for Bio-25, Supherb)

Interventions

Bio-25 (Supherb) DIETARY_SUPPLEMENT

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.

Bio-25 (Supherb)

Placebo (for Bio-25, Supherb) DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18-65 years old
• BMI \> 40 kg/m² or BMI \> 35 kg/m² with comorbidities (See Appendix 1 for the Ministry of health indications for bariatric surgeries) that got the bariatric commission approval of Assuta private hospitals to undergo sleeve gastrectomy surgery
• Willingness to take a probiotic/placebo supplement once a day for 6 months
• Ultrasound diagnosed NAFLD patients
• Reading and speaking Hebrew
• Healthy volunteers:
• Subjects 18-65 years old
• Healthy subjects

You may not qualify if:

• Subject with mental illness or cognitive deterioration
• Use of probiotic/antibiotic 3 mounts before surgery
• Use of other antibiotic for more than 1 week during the study
• Drug addiction
• Excessive alcohol consumption (≥ 30 g/day in men or ≥ 20 g/day in women)
• Treatment with drugs known to cause hepatic steatosis or elevation of liver enzymes (e.g. Corticosteroids, HAART, Amiodarone, high dose estrogens) (see Appendix 2)
• Treatment with drugs or supplements that may improve hepatic steatosis or liver enzymes (Vitamin E, Milk thistle, ω-3 fatty acid, Ursodeoxycholic acid) 3 months prior to the initiation of the study
• Other causes of chronic liver disease ( e.g. viral hepatitis: HBV/HCV +, autoimmune hepatitis, Hemochromatosis, Wilson's disease)
• Diabetic patients who are treated with antidiabetic medications, except diabetic patients who are treated for at least 6 months exclusively with Metformin at a stable dose
• Subjects who began a new lipid reduction medications less than 6 months prior to the initiation of the study
• Subjects with chronic conditions that could interfere with our study: active cancer, organ transplant subjects, advanced kidney or liver disease, inflammatory bowel disease and other systemic inflammatory conditions
• Bariatric surgery in the past

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (3)

• Sherf-Dagan S, Zelber-Sagi S, Buch A, Bar N, Webb M, Sakran N, Raziel A, Goitein D, Keidar A, Shibolet O. Prospective Longitudinal Trends in Body Composition and Clinical Outcomes 3 Years Following Sleeve Gastrectomy. Obes Surg. 2019 Dec;29(12):3833-3841. doi: 10.1007/s11695-019-04057-2.

  PMID: 31301031 DERIVED

• Shenhar-Tsarfaty S, Sherf-Dagan S, Berman G, Webb M, Raziel A, Keidar A, Goitein D, Sakran N, Zwang E, Shapira I, Zeltser D, Berliner S, Rogowski O, Shibolet O, Zelber-Sagi S. Obesity-related acetylcholinesterase elevation is reversed following laparoscopic sleeve gastrectomy. Int J Obes (Lond). 2019 Feb;43(2):297-305. doi: 10.1038/s41366-018-0014-4. Epub 2018 Feb 3.

  PMID: 29491490 DERIVED

• Sherf Dagan S, Zelber-Sagi S, Webb M, Keidar A, Raziel A, Sakran N, Goitein D, Shibolet O. Nutritional Status Prior to Laparoscopic Sleeve Gastrectomy Surgery. Obes Surg. 2016 Sep;26(9):2119-2126. doi: 10.1007/s11695-016-2064-9.

  PMID: 26797718 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Oren Shibolet, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, r&d division

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 14, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

IL (1)