Lactose Intolerance in Infants With Gastrointestinal Disturbances

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2024-04-13

Brief Summary

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This study enrolled thirty infants who presented by GIT symptoms and their CoMiSS was ≥ 12. The patients were assessed upon presentation, after 2 weeks of receiving lactose free diet regimen and 2 weeks after rechallenging them with lactose. Assessments of infants included anthropometric measurements, CoMiSS estimation, Neonatal/Infant Pain Scale (NIPS) and pediatric quality of life assessment (Peds QL). The study aims to detect the frequency of infants with LI with positive Cow's Milk-related Symptom Score (CoMiSS) (which could lead to misdiagnosis as CMPA) and validate of this score to be used as a screening tool for LI in infants.

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Detailed Description

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Conditions

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Lactose Intolerance

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Artificially fed infants

Infants who presented by GIT symptoms and their Cow's Milk-related Symptom Score (CoMiSS) ≥ 12 who received lactose free diet regimen for 2 weeks then received then a regimen containing lactose, a tailored dietary plan was given to each participant, and it included lactose-containing formula and dairy based products like yogurt and cheese were included for infants over 6 months.

Group Type EXPERIMENTAL

lactose free regimen

Intervention Type OTHER

lactose free formula and solid foods that lack lactose for infants above 6 months, ensuring adequate macro and micronutrients intake according to recommended daily allowances (RDA) for age and sex.

Interventions

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lactose free regimen

lactose free formula and solid foods that lack lactose for infants above 6 months, ensuring adequate macro and micronutrients intake according to recommended daily allowances (RDA) for age and sex.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Artificially fed infants.
* Presented with GIT symptoms such as vomiting, diarrhea, abdominal pain, discomfort and distention.
* Cow's Milk-related Symptom Score (CoMiSS) of 12 or higher.

Exclusion Criteria

* Infants with positive family history of Cow's milk protein allergy CMPA.
* Any allergic diseases.
* History of anaphylaxis.
* Atopic dermatitis, swelling of lips or eyelids, urticaria or wheezy chest.

Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No