Screening of Lactose Intolerance Among IBS Patients Diarrhea Dominant

January 4, 2026 updated by: Christina Shahat Ayoub, Assiut University

Screening for Lactose Intolerance Among Patients With IBS Diarrhea Dominant

This cross-sectional study aims to determine the prevalence of lactose intolerance among patients with chronic diarrhea, assess its correlation with age and gender, and evaluate common symptoms in affected patients. The study will collect demographic data, conduct lactose intolerance testing via PCR, and use a symptom questionnaire.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The study is designed as a cross-sectional analysis conducted at a single healthcare center. Its primary objectives are:

To determine the point prevalence of lactose intolerance in patients suffering from chronic diarrhea (lasting more than four weeks).

To explore potential correlations between lactose intolerance and demographic factors such as age and gender.

To identify the most common symptoms associated with lactose intolerance in this patient population.

Methodology:

Data Collection: Demographic information (age, sex, medical history, and diarrhea duration) will be gathered.

Lactose Intolerance Testing: Polymerase Chain Reaction (PCR) will be employed to diagnose lactose intolerance.

Symptom Questionnaire: A standardized questionnaire will be administered to document symptoms like abdominal pain, bloating, flatulence, diarrhea, and nausea.

Study Type

Observational

Enrollment (Estimated)

70

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population consists of adult patients aged 18-70 years diagnosed with chronic diarrhea lasting more than four weeks. Both male and female participants are included. Participants will be recruited from a single healthcare center. They will undergo comprehensive assessments, including demographic profiling, medical history review, and diagnostic testing for lactose intolerance using PCR. The diversity in age and gender ensures that potential correlations with these variables can be analyzed.

Description

Inclusion Criteria:

  • All Patients with IBS diarrhea dominant type meet Rome criteria attending at Al-Rajhy University Hospital during 6 months (from march to September). A patient must have recurrent abdominal pain (at least 1 day per week in the last 3 months) associated with at least two of the following:

    1. Related to defecation (pain improves or worsens with bowel movements).
    2. Change in stool frequency (diarrhea or constipation).
    3. Change in stool form (appearance) (loose, watery, hard, or lumpy).
  • Patients aged >18 years.
  • Both males and females

Exclusion Criteria:

  • -patient aged<18 years old.
  • Patients with chronic diarrhea don't meet Rome criteria
  • patients with malignancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
adult patients aged 18-70 years diagnosed as IBS diarrhea dominant

The target population comprises individuals who meet the following inclusion criteria:

Adults aged between 18 and 70 years.

Diagnosed with IBS diarrhea dominant

Both males and females are eligible for participation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence data on lactose intolerance in patients with IBS diarrhea dominant.
Time Frame: 1 year
The primary outcome is to determine the percentage of patients with chronic diarrhea who test positive for lactose intolerance using PCR testing.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Screening of lactose intolera

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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