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 range6 Months – 24 Months

SexALL

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)

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