13C-Octanoic Acid Breath Test on Gastric Emptying in Celiac Patients With Functional Disorders

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Functional Gastrointestinal Disorders

Treatments: Other: Dietary Intervention (Low Fodmap Gluten Free Diet)

Study type: Interventional

Funder types: Other

Identifiers

NCT07089498

2557

Details and patient eligibility

About

The goal of this interventional study is the evaluation of a diet low in fodmaps on gastric emptying in celiac patients with functional disorders.

Full description

The goal of this interventional study is the evaluation of a diet low in fodmaps on gastric emptying in celiac patients with functional disorders.

The aims of the study are:

• Evaluation of gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet (T1 and T2) in celiac patients with functional dyspepsia and non-celiac patients with functional dyspepsia.
• Evaluation of gastrointestinal symptoms, quality of life, and mental health in patients with non-celiac and celiac functional disorders pre- and post-diet (T1 and T2).

Participants:

• Will run the 13C-octanoic acid breath test pre- and post-diet
• Will complete the VAS, SF-36, and SCL-90 questionnaires pre- and post-diet
• Will follow a low fodmap gluten free diet or a regular gluten-free diet for six weeks Researchers will compare celiac and non-celiac patients.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age: ≥ 18 years old
• gender: male or female
• patients who have signed informed consent
• patients diagnosed with a functional gastrointestinal disorder who meet Rome IV criteria (according to Rome Foundation's latest revision of 2016)

Exclusion criteria

• patients who have not given informed consent
• patients without a diagnosis of a functional gastrointestinal disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Low Fodmap Gluten Free Diet

Experimental group

Description:

Patients received dietary advice in the form of a table divided into two columns, one reporting the allowed food because low in FODMAPs and the other indicating the prohibited food due to its high continent of FODMAPs

Treatment:

Other: Dietary Intervention (Low Fodmap Gluten Free Diet)

Regular Gluten Free Diet

No Intervention group

Description:

Patients received a table containing a list of allowed food based on a regular diet