NCT06931379

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

April 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

April 9, 2025

Last Update Submit

January 4, 2026

Conditions

Keywords

lactose intolerancechronic diarrhea

Outcome Measures

Primary Outcomes (1)

  • Prevalence data on lactose intolerance in patients with IBS diarrhea dominant.

    The primary outcome is to determine the percentage of patients with chronic diarrhea who test positive for lactose intolerance using PCR testing.

    1 year

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at the tropical medicine department

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 17, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

January 6, 2026

Record last verified: 2026-01