A pilot study on the celiac support capsule in patients suffering from celiac disease

A pilot study on the safety and effectiveness of celiac support capsule on clinical symptoms in patients suffering from celiac disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180103038199N17

Enrollment

Registered

2023-06-22

Start date

2023-07-23

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Celiac. Intestinal malabsorption

Interventions

Intervention group: Celiac patients receive 1 Celiac Support capsule (every 6 hours) for 3 months 30 minutes before eating a diet containing gluten..

Eligibility

Sex/Gender

All

Age

5 Years to 30 Years

Inclusion criteria

Inclusion criteria: Having celiac disease Age between 5 to 30 years Not suffering from other diseases Normal liver and kidney status Not pregnant

Exclusion criteria

Exclusion criteria: The occurrence of drug allergy Occurrence of clinical symptoms of celiac disease within 48 hours

Design outcomes

Primary

Measure	Time frame
Clinical symptoms such as diarrhea, urticaria, abdominal pain and bloating, nausea, vomiting, dyspepsia, abdominal pain, headache, fatigue, skin rashes. Timepoint: Weekly. Method of measurement: Checklist.	—

Secondary

Measure	Time frame
Anti-transglutaminase antibody. Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.;Antiendomysial antibody. Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.;Anti-gliadin antibody (AGA). Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.;Intraepithelial lymphocytes (IEL). Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.	—

Measure

Time frame

Anti-transglutaminase antibody. Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.;Antiendomysial antibody. Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.;Anti-gliadin antibody (AGA). Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.;Intraepithelial lymphocytes (IEL). Timepoint: At the beginning of the study and after 3 months of treatment. Method of measurement: Laboratory kit.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVahid Reza Askari

Mashhad University of Medical Sciences

askariv941@mums.ac.ir+98 51 3800 2264

Outcome results

None listed

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