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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Lessening in bloating
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 24 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Lactase enzyme group
In this group, 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, was added 5-30 minutes before feeding.
Intervention: Lactase enzyme (Dietary Supplement)
Lactose-free formula feed group
In this group, lactose-free formula milk/diet was advised.
Intervention: Lactose-free formula feed (Dietary Supplement)
Outcomes
Primary Outcomes
Lessening in bloating
Time Frame: 5 days
It was assessed on the basis of a decrease in the abdominal girth (≤ 1) at the umbilicus by a non- stretchable measuring tape
Resolution of nausea/vomiting no perianal rash or only
Time Frame: 5 days
Decrease in the frequency of nausea/vomiting
Resolution of perianal rash
Time Frame: 5 days
If no perianal rash or only erythema is seen
Resolution of diarrhea
Time Frame: 5 days
It was labeled on the basis of frequency of stools ≤ 4 and consistency of stools ≤ 5 (Bristol Stool Chart, ideal range 3-5)
Reduction in abdominal pain
Time Frame: 5 days
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)
Secondary Outcomes
- Treatment successful(6 days)
Investigators
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research