Clinical trials: Infant Colic
Infantile Colic
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant With Colic Not Responding to Conventional Treatment
This phase IIa study is designed as a multi-centre, single country, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral…
- Trial name
- nocry-a (NCT01309009)
- Testing
- Nepadutant oral solution
- Sponsor
- Menarini Group
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 Colic, Infantile Functional Gastrointestinal Disorders
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants.
- Trial name
- NCT00655083
- Testing
- Nepadutant
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Menarini Group
Infant Colic
Infant Colic Treatment With Probiotics
This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B.
- Trial name
- NCT03467334
- Testing
- B. breve, B. breve plus L. fermentum, Simethicone 20 MG
- Where
- Spain
- Volunteers
- 156 people
- Sponsor
- Mónica Olivares Martín; PhD
Crying
Feeding Intervention for Infants With Crying
The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.
- Trial name
- NCT01017991
- Testing
- Milk based infant formula with probiotic, Milk based infant formula
- Where
- 9 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral…
- Trial name
- no-cry (NCT01258153)
- Testing
- Nepadutant oral solution
- Where
- 9 sites in Germany, Poland and 2 more
- Volunteers
- 115 people
- Sponsor
- Menarini Group
Infant Colic
Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein
Randomized, parallel, double-blind clinical trial, comparing a partially hydrolyzed serum proteins infant formula with a conventional formula with intact protein in healthy infants that suffer from colic
- Trial name
- VEGY-UP (NCT04015089)
- Testing
- Partially hydrolyzed formula (pHF), Standard formula (SF)
- Where
- 2 sites in Spain
- Volunteers
- 156 people
- Sponsor
- Laboratorios Ordesa
Infant Colic
Lactocare Baby Drops in Infants Colic
The objective of this study is to determine an efficacy of the combination of L. rhamnosus 19070-2 (FloraActiveTM) and L. reuteri DSM 122460 (FloraActiveTM) in decreasing cry/fuss in infants aged 4 through 12 weeks with IC.
- Trial name
- LACONIC (NCT02839239)
- Testing
- Drops with lactobacilli and vitamin D3, Drops with vitamin D3
- Volunteers
- 168 people
- Sponsor
- Biocare Copenhagen A/S
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.
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.
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
Infantile Colic
An Infant Formula Trial on Dietary Management of Infantile Colic
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.
- Trial name
- NCT03329222
- Testing
- Specific hydrolysed proteins, Standard cow's milk with prebiotics mixture
- Where
- 2 sites in Singapore, Thailand
- Volunteers
- 5 people
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
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
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
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
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
Infantile Colic, Colic, Infantile
Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic
This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.
- Trial name
- NCT03434249
- Testing
- Bifidobacterium, BB-12® (Bifidolactis Infant)
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- SOFAR S.p.A.
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
Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic
The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria.
- Trial name
- PROBIOC (NCT01887444)
- Testing
- Lactobacillus reuteri DSM17938 probiotic
- Where
- France
- Sponsor
- BioGaia AB