ClinicalTrials.gg
Not yet recruitingNCT06931379Updated Jan 6, 2026

Screening of Lactose Intolerance Among IBS Patients Diarrhea Dominant

An observational study in Lactose Intolerance, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
70
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lactose Intolerance

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Keywords

  • lactose intolerance
  • chronic diarrhea
03

In context

Lactose Intolerance

53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.

This study's planned enrollment of 70 is close to the median of 70 across 11 observational studies indexed under Lactose Intolerance.

Browse Lactose Intolerance studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • -patient aged\<18 years old.
  • Patients with chronic diarrhea don't meet Rome criteria
  • patients with
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2026; primary completion for Jan 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2025
First posted
Apr 17, 2025
StartEst.
Jan 2026
Primary completionEst.
Jan 2027
CompletionEst.
Feb 2027
Last update
Jan 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06931379
Lead sponsor
Assiut University
Responsible party
Christina Shahat Ayoub (resident at the tropical medicine department, Assiut University) — Principal investigator
First posted
Apr 17, 2025
Start date
Jan 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Jan 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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