Lactose IntoleranceNCT06931379
Screening of Lactose Intolerance Among IBS Patients Diarrhea Dominant
An observational study of Lactose Intolerance, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lactose Intolerance
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -patient aged<18 years old.
- Patients with chronic diarrhea don't meet Rome criteria
- patients with malignancies
About this study
Official title: 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.
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.
- Conditions
- Lactose Intolerance
- Keywords
- lactose intolerance, chronic diarrhea
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactose IntoleranceStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Shahat Ayoub, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931379
- Sponsor's protocol ID
- Screening of lactose intolera
- Status last verified
- Jan 2026
- First submitted
- 9 Apr 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Lactose Intolerance Among Patients With IBS Diarrhea Dominant
- ClinicalTrials.gov ID
- NCT06931379
- Acronym / sponsor ID
- Screening of lactose intolera
- Conditions
- Lactose Intolerance
- Keywords
- lactose intolerance, chronic diarrhea
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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:
- Patients aged >18 years.
- Both males and females
Key exclusion criteria (3 listed)
- -patient aged<18 years old.
- Patients with chronic diarrhea don't meet Rome criteria
- patients with malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactose Intolerance, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence data on lactose intolerance in patients with IBS diarrhea dominant. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.