Clinical trials: Colic
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, 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
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
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, 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.
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
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 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
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
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.
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
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
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
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
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
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
Growth, Colic
Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic
The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.
- Trial name
- NCT00929292
- Testing
- Modilac Dahlia 1, Modilac 1
- Where
- 12 sites in France
- Volunteers
- 66 people
- Sponsor
- Sodilac
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
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
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