Investigating the effect of gluten-free diet along with Glyzyme compared to gluten-free diet alone in improving clinical symptoms and laboratory and serological parameters of newly diagnosed celiac patients aged 3-18 years

Investigating the effect of gluten-free diet along with Glyzyme compared to gluten-free diet alone in improving clinical symptoms and laboratory and serological parameters of newly diagnosed celiac patients aged 3-18 years who referred to Children's Medical Center Hospital in 1403-1404

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240507061695N1

Enrollment

Registered

2025-05-31

Start date

2025-05-21

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Celiac. Celiac disease

Interventions

Intervention 1: Intervention group: The people of this group should take three times a day for three months, each time the number of Glezyme tablets produced by Behestan Health Company at the beginnin

Eligibility

Sex/Gender

All

Age

3 Years to 18 Years

Inclusion criteria

Inclusion criteria: All patients with celiac disease based on the ESPGHAN guideline Patients aged 3 to 18 years with celiac disease Absence of hypothyroidism and diabetes

Exclusion criteria

Exclusion criteria: Patients taking any interfering medications or supplements

Design outcomes

Primary

Measure	Time frame
The amount of decrease in anti-TTG IgA serum level. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Measurement of antibody levels in patients' serum by ELISA method.;Clinical findings. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Checklist.	—

Measure

Time frame

The amount of decrease in anti-TTG IgA serum level. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Measurement of antibody levels in patients' serum by ELISA method.;Clinical findings. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Checklist.

—

Secondary

Measure	Time frame
Aspartate transaminase. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Serum level.;ALT. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Serum level.;Hb. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Serum level.;Weight. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Digital Scale.;Height. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Flexible cloth measuring tape.	—

Measure

Time frame

Aspartate transaminase. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Serum level.;ALT. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Serum level.;Hb. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Serum level.;Weight. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Digital Scale.;Height. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of the intervention. Method of measurement: Flexible cloth measuring tape.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHosein Alimadadi

Tehran University of Medical Sciences

cmcpr@tums.ac.ir+98 21 6147 9999

Outcome results

None listed

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