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

Muhammad Aamir Latif50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Lactose Intolerance

Interventions

Lactase enzymeDIETARY_SUPPLEMENT

Patients were given 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, 5-30 minutes before feeding

Lactose-free formula feedDIETARY_SUPPLEMENT

Patients were advised lactose-free formula milk/diet.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 24 Months

Medical Language ↔ Plain English

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)

Locations (1)

Ziauddin University Hospital, Kemari

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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