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NCT Number: NCT06931379

Screening of Lactose Intolerance Among IBS Patients 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Related to defecation (pain improves or worsens with bowel movements).
  • Change in stool frequency (diarrhea or constipation).
  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Screening for Lactose Intolerance Among Patients With IBS Diarrhea Dominant

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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