Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination

November 11, 2023 updated by: Ain Shams University

Open Labeled Randomized Clinical Trial of Introduction of a Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination Protocol

For Patients diagnosed as cow milk protein allergy: Elimination of cow's milk products (CMPs) for 6 months.

All infants were supplemented with Amino Acid-based Formula (AAF) (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet.

For mixed milk fed infants (still receiving breast milk with the formula), mothers were encouraged to continue breast-feeding while avoiding all milk and milk products from their own diet.

Intervention after completing 6 months of eliminating CMPs. The included patients were randomly assigned to one of (2 groups).

  1. Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.
  2. Group II (pHF group) n= 50 Infants in this group were shifted gradually to Partially-hydrolyzed whey formula (pHF) (Liptomil Plus HA infant formula. for another 6 months with continuation of elimination of cow's milk products.

They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF.

Final step: Reintoduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by oral food challenge (OFC).

For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Phase Ⅰ:Initial assessment at enrollment i. Full medical history taking: with emphasis on: Personal History: Age- Sex- Order of birth- Consanguinity-Residence

Main presenting symptoms:

A- Gastrointestinal symptoms: at initial diagnosis According to the clinical presentations, following clinical diagnoses were identified GERD, FPIAP, FPIES, FPE, constipation and combination of symptoms as shown in the following table.

B- Associated systemic allergic manifestations: at initial diagnosis C- CoMiSS: Cow's Milk-related Symptom Score (CoMiSS) at presentation. CMPA diagnosis was confirmed by an elimination diet followed by an oral food challenge.

D- Course of the disease:

E- Dietary and nutritional history:

  1. Breast Feeding: If Yes exclusive for how long?
  2. Artificial feeding: Age of start, type of formula, Indication.
  3. Weaning: Time of start, Type of food given (each food and time of introduction especially cow's milk and CMPs), Any problems during weaning (gastrointestinal, respiratory or skin allergies) and eliciting dose of milk products that caused symptoms.

  4. Accidental intake of raw or heated milk during elimination period and its consequences.

    • Past history: mode of delivery
    • Family history: atopy, siblings with CMPA
    • Medication history: Antireflux medications, laxatives, probiotics. ii. Clinical examination:
    • Anthropometric measurements: (weight &height on Z score, Wt/Ht ratio) using WHO 2006 Growth charts to those aged ≤ 2 years & CDC Growth charts 2000 if >2 years old
    • Signs of allergy: (atopic dermatitis- allergic rhinitis-wheezy chest)
    • Abdomen:(Distension- Tenderness- organomegaly)
    • Perineal area: (Perianal inflammation, napkin rash)

Phase 2: Elimination of CMPs for 6 months. All infants were supplemented with Amino Acid-based Formula (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet. Cow's-milk-based formula and supplementary foods containing CMPs, other animal milk proteins (eg, goat's milk, sheep's milk) were strictly avoided due to cross reactivity.

For mixed milk fed infants (still receiving breast milk with the formula), mothers were encouraged to continue breast-feeding while avoiding all milk and milk products from their own diet Breast feeding mothers excluding cow's milk were prescribed a supplement of 1000 mg of calcium & 10 µg (400 IU) of vitamin D every day

Phase III: Intervention after completing 6 months of eliminating CMPs

o The included patients were randomly assigned to one of (2 groups).

  1. Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.
  2. Group II (pHF group) n= 50 Infants in this group were shifted gradually the same way as OFC (from Amino Acid-based Formula; to Partially-hydrolyzed whey formula (Liptomil Plus HA infant formula; for another 6 months with continuation of elimination of CMPs.

They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF.

Phase IV: Reintroduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by OFC. Tolerance was established by a negative challenge followed by regular ingestion of age-appropriate quantities of cow's milk at home without symptoms, where patients were followed up again for one month to detect any symptoms of intolerance after regular ingestion of milk products

For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Artificially fed infants whether exclusively or complementary.
  2. Confirmed diagnosis of CMPA based on clinical symptoms and signs and followed by withdrawal open re-challenge test

Exclusion Criteria:

  1. Exclusively breast-fed infants.
  2. Anaphylactic type.
  3. Multiple food Allergies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Infants Continuing on amino acid based formula after 6 months elimination
Active Comparator: Infants receiving partially hydrolyzed formula after 6 months of elimination diet
Dietary supplement: Partially hydrolyzed formula
Partially hydrolyzed formula given as the milk supplement for cow milk allergy patients after 6 months of strict elimination diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare the rate of tolerance to cow milk products among patients allocated to partially hydrolyzed formula after 6 months of milk free diet compared to those who completed 1 year of elimination
Time Frame: At the month 13 for both groups and for extra more 30 days of regular ingestion of cow's milk products
Questionnaire done to assess occurrence of following symptoms Vomiting, Hematemesis, Diarrhea (using BRISTOL scale), Constipation, Eczema, Skin rash, Perianal inflammation, weight loss in kilograms or failure to gain weight in kilograms, (Colic, Straining and marked Abdominal distension), skin rash, angioedema, and recurrent respiratory symptoms within two months of following up after milk reintroduction. If any of the previous items is present, then the patient is considered intolerant to milk. All items should be answered by (no) in order to consider the patient tolerant to milk
At the month 13 for both groups and for extra more 30 days of regular ingestion of cow's milk products

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance to pHF after 6 months elimination diet
Time Frame: At the seventh month in the group allocated to receive pHF after six months of elimination diet
To assess tolerance to partially hydrolsed milk formula in the group assigned to ingest pHF via a Questionnaire done to assess occurrence of following symptoms Vomiting, Hematemesis, Diarrhea (using BRISTOL scale), Constipation, Eczema, Skin rash, Perianal inflammation, weight loss in kilograms or failure to gain weight in kilograms, (Colic, Straining and marked Abdominal distension), skin rash, angioedema, and recurrent respiratory symptoms within two months of following up after milk reintroduction. If any of the previous items is present, then the patient is considered intolerant to milk. All items should be answered by (no) in order to consider the patient tolerant to pHF.
At the seventh month in the group allocated to receive pHF after six months of elimination diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 15, 2023

First Submitted That Met QC Criteria

November 11, 2023

First Posted (Estimated)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD444/2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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