Clinical trials: Colic
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
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
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
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.
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 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
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)
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, 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
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
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
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
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
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)
Infantile Colic, Infant Sleeping Habits
Role of ProTectis on Infant Colic and Its Effect on Infant Crying Time and Maternal Mental Health
This study will work on hypothetical assumption that compared to the arm supplemented with placebo (control) group; the L reuteri (intervention) group will lower daily crying/fussing time per 24 hours at one month post…
- Conditions
- Infantile Colic, Infant Sleeping Habits, Maternal Mental Health.
- Trial name
- PRIC-SMM (NCT02094092)
- Testing
- ProTectis drops (five drops per day) for 21 days
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Ferozsons Laboratories Ltd.
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
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)
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
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
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.