Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy (PANDA)
Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy: a Clinical Evaluation
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Grégory ALLAIN
- 電話番号：+33 6 65 74 91 49
- メール：gregory.allain@biofortis.fr
研究連絡先のバックアップ
- 名前：Basile FRILLEY
- 電話番号：+33 6 64 08 92 96
- メール：basile.frilley@biofortis.fr
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
I1. Age ≥ 1 month and < 9 months, I2. Exclusively formula fed and planning to be formula-fed for the duration of the study (food diversification allowed),
I3. With:
a suspicion of CMPA based on suggestive allergic symptoms
- CoMISS score > 10
- And/or acute allergic symptoms
- And/or symptoms suggestive of a Food Protein-Induced Enterocolitis Syndrome (FPIES) (major criteria and <3 minor criteria as per consensus guidelines) (Nowak-Węgrzyn et al. 2017; Beaudoin et al. 2025); OR
a confirmed diagnosis of CMPA within the two months before inclusion:
- IgE-mediated CMPA (documented history of allergic reaction grade ≤ 3 according to the ordinal food allergy severity score oFASS-5 (Fernández-Rivas et al. 2022) following milk protein ingestion, and sensitization to CMP: blood IgE level specific to cow milk≥ 5 kU/L, or positive skin prick test with papule with fresh cow's milk ≥ 8 mm
- or non-IgE-mediated CMPA (documented history of eviction/reintroduction test concluding to CMPA),
- or FPIES (major criteria and ≥3 minor criteria as per consensus guidelines (Nowak-Węgrzyn et al. 2017; Beaudoin et al. 2025), I4. With a written informed consent signed by the father and mother or legal representative(s), I5. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits, I6. With parents willing to achieve all study interventions, I7. At least one of the legal representatives is affiliated with a social security scheme.
Exclusion Criteria:
E1. Birthweight < 2500 g, E2. Gestational age < 37 weeks, E3. Breastfeeding at the time of inclusion and throughout the study period, E4. Already fed with an AAF, or with the investigational formula EHF-AR, E5. History of anaphylactic reaction grade 4 or 5 according to classification oFASS-5 (Fernández-Rivas et al. 2022), or of severe FPIES (previous reaction with any change in behaviour from baseline, any pallor and dehydration requiring intravenous fluids), after mammalian milk exposure, E6. Diagnosed or reported fever and/or infectious diseases, or current systemic infections, or history of congenital infections,
E7. History / diagnosis of:
- GI disease or abnormalities (i.e. short bowel syndrome, chronic intestinal diseases, or GI malformations),
- Or Other malformations, congenital cardiovascular, kidney, liver, pancreas, metabolic or neurological diseases,
- Or Immunodeficiency, or chronic infection requiring long-term treatment,
- Or Genetic diseases and chromosomal abnormalities, E8. Suspected or confirmed food allergies or intolerances, other than CMPA, E9. Currently enrolled in another clinical study, or in exclusion period from a previous clinical study, E10. Whose legal representatives have psychological or linguistic incapability to sign the informed consent, E11. Impossibility to contact the legal representatives in case of emergency.
After V1, the participant will be excluded from participation in this trial if he/she fulfils the following criteria:
E12. No allergic symptoms following the OFC with a standard CMPF.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：First cross-over : EHF-STD / AAF
At V2 visit, an OFC is performed with EHF-STD (extensively hydrolysed anti-regurgitation casein-based formula). At V3 visit, an OFC is performed with AAF (amino acid formula). |
At V2, a randomization is performed and a product is allocated to be administrated in an OFC. According to the randomization the product is EHF-AR or AAF. The progressive doses of 2, 5, 10, 25, 50, and 100 mL are administered to the patient at 15-minute intervals as long as no symptoms appear. If no symptoms appear within 3 hours after administration of the last dose, the product is considered to be tolerated. At V3, the second product is administrated (EHF-AR or AAF)(cross-over). The progressive doses of 2, 5, 10, 25, 50, and 100 mL are administered to the patient at 15-minute intervals as long as no symptoms appear. If no symptoms appear within 3 hours after administration of the last dose, the product is considered to be tolerated. |
|
他の：First cross-over : AAF / EHF-AR
At V2 visit, an OFC is performed with AAF (amino acid formula).
At V3 visit, an OFC is performed with EHF-STD (extensively hydrolysed anti-regurgitation casein-based formula).
|
At V2, a randomization is performed and a product is allocated to be administrated in an OFC. According to the randomization the product is EHF-AR or AAF. The progressive doses of 2, 5, 10, 25, 50, and 100 mL are administered to the patient at 15-minute intervals as long as no symptoms appear. If no symptoms appear within 3 hours after administration of the last dose, the product is considered to be tolerated. At V3, the second product is administrated (EHF-AR or AAF)(cross-over). The progressive doses of 2, 5, 10, 25, 50, and 100 mL are administered to the patient at 15-minute intervals as long as no symptoms appear. If no symptoms appear within 3 hours after administration of the last dose, the product is considered to be tolerated. |
|
他の：Second cross-over : EHF-AR / EHF-STD
From V4 to V5 visit, the subject consumes EHF-AR (extensively hydrolysed anti-regurgitation casein-based formula). From V5 to V6 visit, the subject consumes EHF-STD (extensively hydrolysed casein-based formula). |
At V4, a randomization is performed and a product is allocated for the consumption between V4 and V5. According to the randomization, the product is EHF-AR or EHF-STD. The patient will be fed this product for 2 months. At V5, a second allocation is performed and the second product is consumed between V5 and V6 (EHF-AR or EHF-STD)(crossover). The patient will be fed this product for 2 months. |
|
他の：Second cross-over : EHF-STD / EHF-AR
From V4 to V5 visit, the subject consumes EHF-STD (extensively hydrolysed casein-based formula). From V5 to V6 visit, the subject consumes EHF-AR (extensively hydrolysed anti-regurgitation casein-based formula). |
At V4, a randomization is performed and a product is allocated for the consumption between V4 and V5. According to the randomization, the product is EHF-AR or EHF-STD. The patient will be fed this product for 2 months. At V5, a second allocation is performed and the second product is consumed between V5 and V6 (EHF-AR or EHF-STD)(crossover). The patient will be fed this product for 2 months. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The proportion of infants with CMPA who do not experience any allergic symptoms.
時間枠：5 months
|
The proportion of infants with CMPA who do not experience any allergic symptoms that lead to study discontinuation, as per the investigator, during the first week following the OFC with the EHF-AR formula, including the OFC period itself (between V2 and V3, or V3 and V4).
|
5 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Variation of the CoMISS subscores
時間枠：9 months
|
Variation of the CoMISS subscores (crying, regurgitation, stools, respiratory symptoms, and skin signs) (expressed in arbitrary unit (a.u.), range 0-33) between:
|
9 months
|
|
Variation of the IGSQ score
時間枠：9 months
|
Variation of the IGSQ score (expressed in a.u., range 13-65) from V4 to V5, and from V5 to V6.
|
9 months
|
|
Number of TEAEs
時間枠：9 months
|
|
9 months
|
|
Z-scores for age of anthropometric parameters
時間枠：9 months
|
Z-scores for age of anthropometric parameters (length (cm), weight (g) and head circumference (cm)) at V4, V5 and V6
|
9 months
|
|
Parents' satisfaction
時間枠：9 months
|
Rate of parents' answer to the following questions:
|
9 months
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：GUERVILLE Mathilde、Lactalis
- スタディディレクター：Charlotte MAGNANT、Lactalis
- 主任研究者：Anaïs LEMOINE、Hôpital Armand Trousseau - APHP
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2025-A01706-43
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
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