Abstract
Background: The development of probiotics as therapies to cure or prevent disease lags far behind that of other investigational medications. Rigorously designed phase I clinical trials are nearly non-existent in the field of probiotic research, which is a contributing factor to this disparity. As a consequence, how to appropriately dose probiotics to study their efficacy is unknown. Herein we propose a novel phase I ascending dose trial of Bifidobacterium longum subsp. infantis (B. infantis) to identify the dose required to produce predominant gut colonisation in healthy breastfed infants at 6 weeks of age. Methods/design: This is a parallel-group, placebo-controlled, randomised, double-blind ascending dose phase I clinical trial of dietary supplementation with B. infantis in healthy breastfed infants. The objective is to determine the pharmacologically effective dose (ED) of B. infantis required to produce predominant (>50 %) gut colonisation in breastfed infants at 6 weeks of age. Successively enrolled infant groups will be randomised to receive two doses of either B. infantis or placebo on days 7 and 14 of life. Stool samples will be used to characterise the gut microbiota at increasing doses of B. infantis. Discussion: Probiotic supplementation has shown promising results for the treatment of a variety of ailments, but evidence-based dosing regimes are currently lacking. The ultimate goal of this trial is to establish a recommended starting dose of B. infantis for further efficacy-testing phase II trials designed to evaluate B. infantis for the prevention of atopic dermatitis and food allergies in at-risk children. Trial registration: Clinicaltrials.gov #NCT02286999 , date of trial registration 23 October 2014.
| Original language | English (US) |
|---|---|
| Article number | 340 |
| Journal | Trials |
| Volume | 17 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jul 22 2016 |
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Keywords
- Atopic dermatitis
- Atopy
- Bifidobacterium infantis
- Dose-escalation
- Food allergy
- Phase I clinical trial
- Probiotic
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Pharmacology (medical)
Cite this
Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants : Study protocol for a randomised controlled trial. / Awasthi, Smita; Wilken, Reason; Patel, Forum; German, J. Bruce; Mills, David A.; Lebrilla, Carlito B; Kim, Kyoungmi; Freeman, Samara L.; Smilowitz, Jennifer T.; Armstrong, April W.; Maverakis, Emanual Michael.
In: Trials, Vol. 17, No. 1, 340, 22.07.2016.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants
T2 - Study protocol for a randomised controlled trial
AU - Awasthi, Smita
AU - Wilken, Reason
AU - Patel, Forum
AU - German, J. Bruce
AU - Mills, David A.
AU - Lebrilla, Carlito B
AU - Kim, Kyoungmi
AU - Freeman, Samara L.
AU - Smilowitz, Jennifer T.
AU - Armstrong, April W.
AU - Maverakis, Emanual Michael
PY - 2016/7/22
Y1 - 2016/7/22
N2 - Background: The development of probiotics as therapies to cure or prevent disease lags far behind that of other investigational medications. Rigorously designed phase I clinical trials are nearly non-existent in the field of probiotic research, which is a contributing factor to this disparity. As a consequence, how to appropriately dose probiotics to study their efficacy is unknown. Herein we propose a novel phase I ascending dose trial of Bifidobacterium longum subsp. infantis (B. infantis) to identify the dose required to produce predominant gut colonisation in healthy breastfed infants at 6 weeks of age. Methods/design: This is a parallel-group, placebo-controlled, randomised, double-blind ascending dose phase I clinical trial of dietary supplementation with B. infantis in healthy breastfed infants. The objective is to determine the pharmacologically effective dose (ED) of B. infantis required to produce predominant (>50 %) gut colonisation in breastfed infants at 6 weeks of age. Successively enrolled infant groups will be randomised to receive two doses of either B. infantis or placebo on days 7 and 14 of life. Stool samples will be used to characterise the gut microbiota at increasing doses of B. infantis. Discussion: Probiotic supplementation has shown promising results for the treatment of a variety of ailments, but evidence-based dosing regimes are currently lacking. The ultimate goal of this trial is to establish a recommended starting dose of B. infantis for further efficacy-testing phase II trials designed to evaluate B. infantis for the prevention of atopic dermatitis and food allergies in at-risk children. Trial registration: Clinicaltrials.gov #NCT02286999 , date of trial registration 23 October 2014.
AB - Background: The development of probiotics as therapies to cure or prevent disease lags far behind that of other investigational medications. Rigorously designed phase I clinical trials are nearly non-existent in the field of probiotic research, which is a contributing factor to this disparity. As a consequence, how to appropriately dose probiotics to study their efficacy is unknown. Herein we propose a novel phase I ascending dose trial of Bifidobacterium longum subsp. infantis (B. infantis) to identify the dose required to produce predominant gut colonisation in healthy breastfed infants at 6 weeks of age. Methods/design: This is a parallel-group, placebo-controlled, randomised, double-blind ascending dose phase I clinical trial of dietary supplementation with B. infantis in healthy breastfed infants. The objective is to determine the pharmacologically effective dose (ED) of B. infantis required to produce predominant (>50 %) gut colonisation in breastfed infants at 6 weeks of age. Successively enrolled infant groups will be randomised to receive two doses of either B. infantis or placebo on days 7 and 14 of life. Stool samples will be used to characterise the gut microbiota at increasing doses of B. infantis. Discussion: Probiotic supplementation has shown promising results for the treatment of a variety of ailments, but evidence-based dosing regimes are currently lacking. The ultimate goal of this trial is to establish a recommended starting dose of B. infantis for further efficacy-testing phase II trials designed to evaluate B. infantis for the prevention of atopic dermatitis and food allergies in at-risk children. Trial registration: Clinicaltrials.gov #NCT02286999 , date of trial registration 23 October 2014.
KW - Atopic dermatitis
KW - Atopy
KW - Bifidobacterium infantis
KW - Dose-escalation
KW - Food allergy
KW - Phase I clinical trial
KW - Probiotic
UR - http://www.scopus.com/inward/record.url?scp=84979084540&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84979084540&partnerID=8YFLogxK
U2 - 10.1186/s13063-016-1467-1
DO - 10.1186/s13063-016-1467-1
M3 - Article
C2 - 27449926
AN - SCOPUS:84979084540
VL - 17
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 340
ER -