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Completed

NCT Number: NCT02026518

Effect of Cholecalciferol, Soy Isoflavones in Patients With Irritable Bowel Syndrome

Fasting blood specimens will be taken from the patients with IBS that have inclusion criteria. First, the objectives and method of study will be explained to the patients and informed consent form will be taken from them. They will be divided into 4 groups by an adjusted randomized blocking and the clinical outcomes, quality of life, emotional stress questionnaires will be completed before and after intervention. During 6 weeks, they will receive 2 capsules of soy isoflavones per day, 50000IU vitamin D biweekly in addition to the other placebo form, both of them and placebo of both. At the end, body mass index ( BMI), serum TNF-Alpha, TAC, gene expression of GATA3, ROR gamma, FOXP3 in lymphocytes and gut permeability will be measured. The quantity of polymorphisms of vitamin D and estrogen receptors will be determined.

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Key information

Conditions

Irritable Bowel Disease Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Gastrointestinal Clinics of Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-75 yrs
  • patients with Irritable Bowel Syndrome (IBS) according to ROME III criteria
  • BMI 18-25
  • a- no intestinal organic diseases b- no intestinal infection c- no history of chronic gastrointestinal and colorectal diseases d- no intestinal major surgery
  • no regular use of antibiotics, anti-constipation and anti-diarrhea, immune suppressors, metoclopramide, cisapride, diphenoxylate, opium and non-steroidal anti-inflammatory drugs
  • no pregnancy and lactation
  • not athlete or bed rest
  • no history of breast cancer in herself or her family
  • no severe psychosis

Exclusion criteria

  • a- use of soy isoflavones or vitamin D one year before the study b- use of soy milk or soy nuts during study
  • diet changes during study
  • use of artificial sweetener 2 days before study
  • no desire to complete the study
  • adverse effect of supplement
  • pregnancy during study

Treatment and study plan

Soy isoflavones

Dietary Supplement

Cholecalciferol

Dietary Supplement

Other names: Vitamin D

Placebo of soy isoflavones

Dietary Supplement

placebo of cholecalciferol

Dietary Supplement

Primary outcomes

  1. Change from baseline in Clinical Outcomes (pain, flatulence, diarrhea, constipation ) at 6 weeks

    Time frame: 6 weeks

Secondary outcomes

  1. Change of baseline in gut permeability as efficacy at 6 weeks

    Time frame: 6 weeks

  2. Change of baseline in antioxidant status as efficacy at 6 weeks

    Time frame: 6 weeks

  3. Change of baseline in inflammation status as efficacy at 6 weeks

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 3, 2014
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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