The effects of soy milk consumption on gut microbium community, inflammatory markers, quality of life, symptoms and disease severity in patients with colitits ulcerative

Not Applicable

• Conditions: colitis ulcerative.; Ulcerative colitis, unspecified

• Registration Number: IRCT20181205041859N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 February 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients with colitits ulcerative with moderate severity
body mass index between 18.5 and 30

Exclusion Criteria

Alteration in type of drugs used for treatment of IBD within last 3 months
Having other gut diseases such as related cancers and infections
Pregnancy and lactation
Antibiotic use during last month
Consumption of probiotic products during last month
Admitting in hospital during last 3 months
History of gut infections during last 3 months
Using multivitamin/mineral supplements during last month

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiota community. Timepoint: at the baseline and end of intervention. Method of measurement: real-time PCR method.;Fecal calpotectin. Timepoint: at the baseline and end of intervention. Method of measurement: ELISA.;Fecal lactoferrin. Timepoint: at the baseline and end of intervention. Method of measurement: ELISA.

Secondary Outcome Measures

Name	Time	Method
Serum hs-CRP levels. Timepoint: at the baseline and end of intervention. Method of measurement: ELISA.;Disease severity for colitis ulcerative. Timepoint: at the baseline and end of intervention. Method of measurement: mayo-score questionnaire for colitis ulcerative.;Disease symptoms such as diarrhea, presence of blood in stool and stomachache. Timepoint: at the baseline and end of trial. Method of measurement: questionnaire.;Serum TNF-a levels. Timepoint: at the baseline and end of trial. Method of measurement: ELISA.;Serum IL-1B levels. Timepoint: at the baseline and end of trial. Method of measurement: ELISA.;Patients quality of life. Timepoint: at the baseline and end of trial. Method of measurement: questionnaire.