An interventional study of Lactase enzyme and Lactose-free formula feed in Secondary Lactose Intolerance, sponsored by Muhammad Aamir Latif. Completed at 1 site in Pakistan. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Muhammad Aamir Latif · Not applicable, Interventional, and Treatment
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.
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.
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's enrollment of 50 is above the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →Muhammad Aamir Latif is the lead sponsor of 57 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
In this group, 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, was added 5-30 minutes before feeding.
Dietary Supplement: Lactase enzyme
In this group, lactose-free formula milk/diet was advised.
Dietary Supplement: Lactose-free formula feed
Patients were given 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, 5-30 minutes before feeding
Patients were advised lactose-free formula milk/diet.
Resolution of diarrhea
It was labeled on the basis of frequency of stools ≤ 4 and consistency of stools ≤ 5 (Bristol Stool Chart, ideal range 3-5)
Time frame: 5 days
Reduction in abdominal pain
A score of ≤ 4, assessed on the basis of faces pain score revised chart (FPS-R), was considered as reduction in pain (a higher score indicating more severe pain)
Time frame: 5 days
Lessening in bloating
It was assessed on the basis of a decrease in the abdominal girth (≤ 1) at the umbilicus by a non- stretchable measuring tape
Time frame: 5 days
Resolution of nausea/vomiting no perianal rash or only
Decrease in the frequency of nausea/vomiting
Time frame: 5 days
Resolution of perianal rash
If no perianal rash or only erythema is seen
Time frame: 5 days
Treatment successful
The secondary outcome was treatment success assessed on the basis of all 3 conditions fulfilled, i.e., diarrhea (frequency \< 4 stools, consistency \< 5) lasting less than 5 days, stool pH \> 6, and hospital stays \< 5 days.
Time frame: 6 days
Plan to share: No — Data can be shared on a reasonable request.
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Jul 2024, 25 months.
Of 22 interventional studies with no phase under Lactose Intolerance, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 25 months is above that.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lactase
Muhammad Aamir Latif