Skip to content

Effect of Riboflavin in treatment of irritable bowel syndrome

The effect of Riboflavin supplement on mental health and clinical outcomes in patients with irritable bowel syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090901002394N52
Enrollment
40
Registered
2025-01-04
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable bowel syndrome. Irritable bowel syndrome

Interventions

Intervention 1: Intervention group: Vitamin B2 with a dose of 50 mg produced by Hakiman Teb once a day for 8 weeks. Intervention 2: Control group: The placebo contains starch and Avicel and looks simi

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18 to 65 years Patients with irritable bowel syndrome according to the gastroenterologist diagnosis based on ROME-IV criteria (Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: 1.Related to defecation 2.Associated with a change in frequency of stool 3.Associated with a change in form (appearance) of stool, and absence of pathological findings in digestive examinations Dairy consumption less than two units per day Having a score greater than 3 in the Hospital Anxiety and Depression Scale (HADS) questionnaire

Exclusion criteria

Exclusion criteria: Any organic intestinal disease (diagnosis based on colonoscopy in the last 5 years) and intestinal infection (diagnosis based on stool culture in suspected samples) Medical history of chronic gastrointestinal and colorectal disease Any major bowel surgery Suffering from uncontrolled systemic diseases and diabetes Regular use of laxatives or anti-diarrheal drugs or digestive motility modifiers such as Metoclopramide, Cisapride, narcotics, Diphenoxylate, etc Taking drugs that increase bleeding from the intestinal mucosa, such as Aspirin, Warfarin, Heparin, etc Pregnancy or breastfeeding, being an athlete or being hospitalized Alcohol consumption Taking any type of nutritional supplement regularly (more than 2 times a week)

Design outcomes

Primary

MeasureTime frame
Mental health (depression and anxiety). Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Hospital Anxiety and Depression Scale.;Severity of clinical outcomes. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Irritable bowel syndrome Symptom Severity Scale.

Secondary

MeasureTime frame
Quality of life. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Irritable bowel syndrome quality of life questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGhazaleh Mahdavi Mazdeh

Iran University of Medical Sciences

ghazalehmahdavi@ymail.com+98 21 8670 4805

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026