Clinical trial · Interventional
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia
NCT01766804CI-TRIAL-00034071CALLcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation in children treated for acute lymphoblastic leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bovine Colostrum | Dietary Supplement | — | UNRESOLVED |
| placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bovine colostrum
- description
- A daily supplement of bovine colostrum powder.
- interventionNames
- Dietary Supplement: Bovine Colostrum
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- A daily placebo supplement consisting of whole milk powder and whey protein.
- interventionNames
- Dietary Supplement: placebo
Primary outcomes (1)
- measure
- Days with fever. Fever
- timeFrame
- Measured two times daily and on suspicion during the intervention period, up to four weeks,
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol Exclusion Criteria: * Milk Allergy * Lactose intolerance
References
Publications (2)
- DERIVEDRathe M, De Pietri S, Wehner PS, Frandsen TL, Grell K, Schmiegelow K, Sangild PT, Husby S, Muller K. Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia: A Randomized, Double-Blind, Placebo-Controlled Trial. JPEN J Parenter Enteral Nutr. 2020 Feb;44(2):337-347. doi: 10.1002/jpen.1528. Epub 2019 Mar 12. PMID 30861163
- DERIVEDShen RL, Pontoppidan PE, Rathe M, Jiang P, Hansen CF, Buddington RK, Heegaard PM, Muller K, Sangild PT. Milk diets influence doxorubicin-induced intestinal toxicity in piglets. Am J Physiol Gastrointest Liver Physiol. 2016 Aug 1;311(2):G324-33. doi: 10.1152/ajpgi.00373.2015. Epub 2016 Jul 21. PMID 27445347