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

NCT06827405 | Completed

• 1 other identifier: ZUHKARACHI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Lactose Intolerance

Outcome Measures

Primary Outcomes (5)

• 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 nausea/vomiting no perianal rash or only

  Decrease in the frequency of nausea/vomiting

  5 days

• Resolution of perianal rash

  If no perianal rash or only erythema is seen

  5 days

Secondary Outcomes (1)

• Treatment successful

  6 days

Study Arms (2)

Lactase enzyme group

EXPERIMENTAL

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

Lactose-free formula feed group

EXPERIMENTAL

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

Dietary Supplement: Lactose-free formula feed

Interventions

Lactase enzyme DIETARY_SUPPLEMENT

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

Lactase enzyme group

Lactose-free formula feed DIETARY_SUPPLEMENT

Patients were advised lactose-free formula milk/diet.

Lactose-free formula feed group

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Ziauddin University Hospital, Kemari

Karachi, Sindh, 75620, Pakistan

Location

MeSH Terms

Interventions

Lactase

Intervention Hierarchy (Ancestors)

beta-Galactosidase; Galactosidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Fatima Ghayas, FCPS

  Hamdard University Hospital, Karachi

  PRINCIPAL INVESTIGATOR

• Heena Ghayas, FCPS

  Ziauddin University Karachi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: June 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)