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

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.

Study Overview

• Status: Completed
• Conditions: Secondary Lactose Intolerance
• Intervention / Treatment: Dietary supplement: Lactase enzyme; Dietary supplement: Lactose-free formula feed

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75620
      • Ziauddin University Hospital, Kemari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Lactase enzyme; Patients were given 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, 5-30 minutes before feeding
Experimental: Lactose-free formula feed group; In this group, lactose-free formula milk/diet was advised.	Dietary supplement: Lactose-free formula feed; Patients were advised lactose-free formula milk/diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of nausea/vomiting no perianal rash or only	Decrease in the frequency of nausea/vomiting	5 days
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)	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)	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	5 days
Resolution of perianal rash	If no perianal rash or only erythema is seen	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 days

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• Investigators: Principal Investigator: Fatima Ghayas, FCPS, Hamdard University Hospital, Karachi; Study Director: Heena Ghayas, FCPS, Ziauddin University Karachi

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Neoplastic Processes; Malabsorption Syndromes; Carbohydrate Metabolism, Inborn Errors; Neoplasm Metastasis; Lactose Intolerance
• Other Study ID Numbers: ZUHKARACHI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No