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

M

Muhammad Aamir Latif

Status

Completed

Conditions

Secondary Lactose Intolerance

Treatments

Dietary Supplement: Lactase enzyme
Dietary Supplement: Lactose-free formula feed

Study type

Interventional

Funder types

Other

Identifiers

NCT06827405
ZUHKARACHI

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

6 to 24 months old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Lactase enzyme group
Experimental group
Description:
In this group, 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, was added 5-30 minutes before feeding.
Treatment:
Dietary Supplement: Lactase enzyme
Lactose-free formula feed group
Experimental group
Description:
In this group, lactose-free formula milk/diet was advised.
Treatment:
Dietary Supplement: Lactose-free formula feed

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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