CompletedNot Applicable

Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula

Pakistan50 participantsStarted 2022-06-01

Plain-language summary

This study aimed to fill the gaps by comparing the effectiveness of oral lactase enzyme and lactose free formula in the management of secondary lactose intolerance in persistent and severe persistent diarrhea.

Who can participate

Age range

6 Months – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Both genders * Aged 6-24 months * Presented with persistent or severe persistent diarrhea due to secondary lactose intolerance * Patients on formula or mixed feeding, or formula/cow/buffalo milk Exclusion Criteria: * Severe acute malnutrition * Hemodynamic instability (shock) * Those on oral antibiotics or on excessive juices * With conditions of malabsorptive states (celiac disease, protein losing enteropathy, or irritable bowel syndrome)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Resolution of diarrhea

Timeframe: 5 days

Reduction in abdominal pain

Timeframe: 5 days

Lessening in bloating

Timeframe: 5 days

Resolution of nausea/vomiting no perianal rash or only

Timeframe: 5 days

Resolution of perianal rash

Timeframe: 5 days

Trial details

NCT IDNCT06827405

SponsorMuhammad Aamir Latif

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Secondary Lactose Intolerance trials

Who can participate

Age range

6 Months – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.