NCT07687797

Brief Summary

Partially hydrolysed whey based formula in differentiation between non IgE gastrointestinal cow's milk protein allergy and milk intolerance

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Dec 2027

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Cow Milk IntoleranceCow Milk Protein Allergy

Outcome Measures

Primary Outcomes (1)

  • determining the frequency of cow milk intolerance diagnosis among patients suspected for cow milk protein allergy

    12 weeks

Study Arms (2)

classic algorithm pathway receiving amino acid based formula

ACTIVE COMPARATOR

study pathway receiving partially hydrolyzed whey based formula

Dietary Supplement: amino acid based formula

study pathway receiving partially hydrolyzed whey based formula

EXPERIMENTAL
Dietary Supplement: partially hydrolysed whey based formula

Interventions

partially hydrolysed whey based formulaDIETARY_SUPPLEMENT

partially hydrolysed whey based formula

study pathway receiving partially hydrolyzed whey based formula
amino acid based formulaDIETARY_SUPPLEMENT

classic pathway of cow milk protein intolerance

classic algorithm pathway receiving amino acid based formula

Eligibility Criteria

Age1 Month - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • months of age
  • formula fed infants
  • CoMiSS score above 10
  • Repeated body mucoid stool

You may not qualify if:

  • IgE mediated disease
  • Skin allergy
  • Respiratory symptoms
  • Exclusive or mixed breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Ain Shams University

Cairo, 11566, Egypt

Location

Central Study Contacts

Mostafa Elhodhod

CONTACT

+2010065541445moshodhod@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of pediatrics

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)