Clinical trials: Colic
Gut Microbiota Modulation
STUDY OF THE EFFECTS OF L. CASEI DG® (ENTEROLACTIS BABY) IN HEALTHY PRETERM AND FULL-TERM INFANTS.
The goal of this clinical trial was to learn whether giving Enterolactis Baby®, a probiotic food supplement containing Lactobacillus casei DG® (under the new taxonomical denomination: Lacticaseibacillus paracasei DG, CNCM…
- Trial name
- NCT07882537
- Testing
- Enterolactis Baby® drops
- Where
- Italy
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Alfasigma S.p.A.
Colic, Infantile
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic
This is a double-blind, multi-center, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time.
- Trial name
- NCT05512234
- Testing
- L. reuteri
- Where
- 3 sites in Ireland, Mexico and 1 more
- Volunteers
- 102 people
- Sponsor
- BioGaia AB
Infantile Colic
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.
- Trial name
- NCT07190859
- Testing
- L. reuteri
- Where
- 4 sites in Bulgaria
- Volunteers
- 50 people
- Sponsor
- BioGaia AB
Infantile Colic
Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.
- Trial name
- PIXAR (NCT05432479)
- Testing
- Probiotic
- Where
- 2 sites in United States, India
- Volunteers
- 101 people
- Sponsor
- The Archer-Daniels-Midland Company
Infantile Colics, Constipation
Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
This is a randomized, single-blind, placebo-controlled study to evaluate the efficacy of the dietary supplement BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria) in managing functional…
- Conditions
- Infantile Colics, Constipation, Infantile Diarrhea, Atopic Dermatitis
- Trial name
- NCT07444008
- Testing
- BioAmicus Complete
- Where
- Russia
- Volunteers
- 140 people
- Sponsor
- NovoNatum Ltd
Infantile Colic
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.
- Trial name
- NCT06462651
- Testing
- L. reuteri
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- BioGaia AB
Infant Colic
Prospective Study to Determine the Factors Influencing Infant Colic
Randomized study to determine the effect of a commercialized combination of 2 probiotic strains (Bifidobacterium Longum and Pediococcus pentosaceus) and the impact of feeding type in babies diagnosed with colic under Roma IV…
- Trial name
- NCT05271747
- Testing
- AB-Kolicare, Reuteri gotas
- Where
- 4 sites in Mexico, Spain
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- AB Biotics, SA
Functional Gastrointestinal Disorders
Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
This study aims to assess the evolution of functional gastrointestinal disorders (FGIDs) in infants fed with a new infant formula, using the Gastrointestinal (GI) and gastroesophageal reflux (GER) (GIGER) scale through an…
- Trial name
- NCT06488274
- Testing
- New infant formula
- Where
- 4 sites in France
- Volunteers
- 139 people
- Sponsor
- United Pharmaceuticals
Gastrointestinal Disorder, Functional, Regurgitation, Gastric
Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study
To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from…
- Conditions
- Gastrointestinal Disorder, Functional, Regurgitation, Gastric, Colic, Infantile, Constipation - Functional
- Trial name
- TIGER (NCT05363553)
- Testing
- Infant formula based on whole goat milk, infant formula based on cow milk proteins
- Where
- Thailand
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited
Infantile Colic
Effect of Probiotics on Infantile Colic Symptoms
The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying…
- Trial name
- EPIC (NCT06385054)
- Testing
- Probiotic
- Where
- 10 sites in France
- Volunteers
- 70 people
- Sponsor
- Lallemand Health Solutions
Colic
Human Milk Oligosaccharide (HMO) Supplementation in Colic Management
Efficacy and tolerability of a composition comprising of HMO in a supplement format on colic management: a double-blind, randomized, placebo-controlled trial
- Trial name
- NCT05554991
- Testing
- HMO, Parental reassurance and support
- Where
- 7 sites in Italy, Spain
- Volunteers
- 5 people
- Sponsor
- Société des Produits Nestlé (SPN)
Colic
First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
This randomized, open label, dose-response study will be realized at the first line with Bactecal® D Liquid. The objective is to investigate Bactecal® D Liquid in the context of infantile colics.
- Trial name
- BACTECOLIC (NCT05052476)
- Testing
- Bactecal® D Liquid
- Where
- Belgium
- Volunteers
- 68 people
- Sponsor
- Astel Medica
Colic
The Effect of Probiotics on Symptoms of Infantile Colic
The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily…
- Trial name
- PROCOLIN (NCT05198700)
- Testing
- Probiotic Formulation
- Where
- 5 sites in Spain
- Sponsor
- Lallemand Health Solutions
Infantile Colic, Constipation
Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns
This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food…
- Conditions
- Infantile Colic, Constipation, Infantile Diarrhea, Gastro Esophageal Reflux
- Trial name
- NCT04262648
- Testing
- Lactobacillus Reuteri
- Where
- 2 sites in Russia
- Volunteers
- 90 people
- Sponsor
- NovoNatum Ltd
Colic
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance.
- Trial name
- NCT01532518
- Testing
- Nepadutant
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Menarini Group
Infantile Colic
The COLIC Study: Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic
To investigate whether B. infantis EVC001 colonization in the infant gut can reduce symptoms of colic
- Trial name
- COLIC (NCT05129384)
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Evolve BioSystems, Inc.
Infant Nutrition Disorders, Gastrointestinal Dysfunction
Management of Infant Digestive Disorders and Quality of Life
The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.
- Trial name
- NCT04462640
- Testing
- Management of Infant Digestive Disorders and Quality of Life
- Where
- France
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Colic, Infantile
Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic
This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.
- Trial name
- NCT03106285
- Testing
- Lactobacillus reuteri DSM17938
- Where
- Indonesia
- Sponsor
- BioGaia AB
Infantile Colic
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.
- Trial name
- Coco (NCT01721850)
- Testing
- control formula, intervention formula 1, intervention formula 2
- Where
- 18 sites in Germany, Italy
- Volunteers
- 169 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Functional Gastrointestinal Disorders, Infantile Colic
Observational Prospective Study With Probiotic Supplementation on Infants With FGDI
This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)
- Conditions
- Functional Gastrointestinal Disorders, Infantile Colic, Functional Constipation
- Trial name
- NCT04944628
- Testing
- Probiotic
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- AB Biotics, SA