Probiotic in ROUX_en_Y obesity surgery on gastrointestinal function and metabolic factors and weight changes

Phase 3

• Conditions: Condition 1: Morbid obesity. Condition 2: Bariatric surgery.; Morbid (severe) obesity due to excess calories; Bariatric surgery status; E66.01; Z98.84

• Registration Number: IRCT20220702055340N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

BMI = 45 kg/m2
35 =BMI =40 kg/m2 associated with comorbidity

Exclusion Criteria

having evidence of chronic gastrointestinal, hepatic or renal disorders
having evidence of chronic hepatic disorders
having evidence of chronic renal disorders
Pregnancy
Breastfeeding in women
Recieving antibiotics, probiotics or probiotic enriched foods, non-steroid anti-inflammatory drugs (NSAID) or insulin within 4 weeks before the study initiation.
History of gastrointestinal surgeries

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Function. Timepoint: start receiving medication 1 week after surgery and start investigation, 5week after surgery, 9weeks after surgery, 12 week after surgery then 6 month after surgery. Method of measurement: Using of Gastrointestinal Quality of Life index questionnaire.;Blood sugar. Timepoint: Before surgery and after surgery for up to 6 months. Method of measurement: Blood test.;Liver enzyme. Timepoint: Before surgery and after surgery for up to 6 months. Method of measurement: Blood test.;Triglyceride. Timepoint: Before surgery and after surgery for up to 6 months. Method of measurement: Blood test.;HbA1C. Timepoint: Before surgery and after surgery for up to 6 months. Method of measurement: Blood test.