NCT06827405

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

Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula in the Management of Secondary Lactose Intolerance in Persistent and Severe Persistent Diarrhea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Muhammad Aamir Latif · Academic / Other
• Sex: All
• Age: 6 Months – 24 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Although it is well understood that oral lactase enzyme can play a pivotal role in hastening recovery due to secondary lactose intolerance in persistent diarrhea, there is limited local data available in this regard. If exogenous oral lactase enzyme is found to be more effective, it would help children receive uninterrupted milk and milk-based diet during the diarrheal episode, as the former would aid digestion and absorption of lactose, thus providing the necessary nutrients especially (calcium) and vitamins so vital in this period of rapid growth.

Conditions

• Secondary Lactose Intolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactase enzyme	Patients were given 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, 5-30 minutes before feeding
DIETARY_SUPPLEMENT	Lactose-free formula feed	Patients were advised lactose-free formula milk/diet.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2025-02-14
• Last updated: 2025-02-19

Locations

1 site across 1 country: Pakistan