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

NCT ID: NCT06827405

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-07-31

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.

Conditions

Secondary Lactose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lactase enzyme

Intervention Type: DIETARY_SUPPLEMENT

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

Lactose-free formula feed group

In this group, lactose-free formula milk/diet was advised.

Group Type: EXPERIMENTAL

Lactose-free formula feed

Intervention Type: DIETARY_SUPPLEMENT

Patients were advised lactose-free formula milk/diet.

Interventions

Lactase enzyme

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

Intervention Type: DIETARY_SUPPLEMENT

Lactose-free formula feed

Patients were advised lactose-free formula milk/diet.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhammad Aamir Latif

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Aamir Latif

Research Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fatima Ghayas, FCPS

Role: PRINCIPAL_INVESTIGATOR

Hamdard University Hospital, Karachi

Heena Ghayas, FCPS

Role: STUDY_DIRECTOR

Ziauddin University Karachi

Locations

Ziauddin University Hospital, Kemari

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

ZUHKARACHI

Identifier Type: -

Identifier Source: org_study_id