Clinical trials: Functional Constipation
- Condition Functional Constipation
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Irritable Bowel Syndrome With Constipation
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation
The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years.
- Trial name
- LIN-MD-63 (NCT02559817)
- Testing
- Linaclotide Dose A, Linaclotide Dose B, Linaclotide Dose C
- Where
- 48 sites in United States, Canada
- Volunteers
- 101 people
- Sponsor
- Forest Laboratories
Constipation
Single Dose Pharmacokinetics of Prucalopride in Paediatric Subjects, With Functional Faecal Retention
The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal retention.
- Trial name
- NCT01674166
- Testing
- prucalopride
- Volunteers
- 38 people
- Sponsor
- Movetis
Constipation - Functional
Lubiprostone in Children With Functional Constipation
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
- Trial name
- NCT02042183
- Testing
- Lubiprostone
- Where
- 117 sites in United States, Belgium and 5 more
- Volunteers
- 606 people
- Sponsor
- Sucampo Pharma Americas, LLC
Functional Constipation, Irritable Bowel Syndrome With Constipation
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria…
- Trial name
- NCT04026113
- Testing
- Linaclotide
- Where
- 115 sites in United States, Belgium and 12 more
- Volunteers
- 438 people
- Sponsor
- AbbVie
Functional Constipation
A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility.
- Trial name
- NCT05760313
- Testing
- Linaclotide
- Where
- 38 sites in United States, Bulgaria and 5 more
- Volunteers
- 19 people
- Sponsor
- AbbVie
Inflammatory Bowel Diseases, Irritable Bowel Syndrome
Fecal Calprotectin Collection Protocol
The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study.
- Conditions
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Ulcerative Colitis, Crohn Disease
- Trial name
- CALFE (NCT03143517)
- Testing
- Stool collection
- Where
- 13 sites in United States
- Volunteers
- 240 people
- Sponsor
- DiaSorin Inc.
Irritable Bowel Syndrome With Constipation, Functional Constipation
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants…
- Trial name
- NCT04166058
- Testing
- Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers), Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
- Where
- 72 sites in United States, Canada and 2 more
- Volunteers
- 381 people
- Sponsor
- AbbVie
Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases), Irritable Bowel Syndrome With Constipation (IBS-C)
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
The objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.
- Trial name
- NCT03471728
- Testing
- linaclotide
- Where
- 47 sites in Japan
- Volunteers
- 2,475 people
- Sponsor
- Astellas Pharma Inc
Functional Constipation (FC), Chronic Idiopathic Constipation (CIC)
A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility.
- Trial name
- NCT05652205
- Testing
- Linaclotide
- Where
- 48 sites in United States, Bulgaria and 2 more
- Volunteers
- 123 people
- Sponsor
- AbbVie
Functional Constipation
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation.
- Trial name
- NCT04110145
- Testing
- Linaclotide
- Where
- 18 sites in United States
- Volunteers
- 35 people
- Sponsor
- Allergan
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
Functional Constipation
Evaluation of the Efficacy of a New Specific Infant Formula in Case of Functional Constipation
This study aims to assess the clinical efficacy, safety and tolerance of a new formula containing a prebiotic and a mix of probiotics in the specific population of infants suffering from functional constipation through a…
- Trial name
- NCT05340712
- Testing
- new infant formula, Standard formula
- Where
- 2 sites in Italy
- Volunteers
- 80 people
- Sponsor
- United Pharmaceuticals
Constipation, Signs and Symptoms
Tolerability and Functional Assessment of a Novel Children's Synbiotic
Recent data support the use of specific probiotic strains in a pediatric population. However, given the wide number of commercial products available, and contradictory data in the literature, healthcare providers and consumers…
- Conditions
- Constipation, Signs and Symptoms, Digestive Signs and Symptoms, Infrequent or Difficult Evacuation
- Trial name
- PDS-08™ (NCT04534036)
- Testing
- PDS-08
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Seed Health
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
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
Constipation
Prucalopride in Paediatric Subjects, With Functional Faecal Retention
The purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric…
- Trial name
- NCT01670669
- Testing
- prucalopride
- Volunteers
- 37 people
- Sponsor
- Movetis
Chronic Functional Constipation
Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months
The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-
- Trial name
- NCT02751411
- Testing
- micro-enema with Promelaxin, Macrogol 4000
- Where
- 4 sites in Italy
- Volunteers
- 158 people
- Sponsor
- Aboca Spa Societa' Agricola
Constipation
A Study of Prucalopride For Functional Constipation in Children and Teenagers
Functional constipation is a condition when it is very hard to pass a stool that is not due to any other health problem or to medicines being taken. This condition is more common in children and teenagers.
- Trial name
- NCT04759833
- Testing
- Prucalopride
- Where
- 41 sites in United States
- Volunteers
- 175 people
- Sponsor
- Takeda
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
Functional Constipation in Children Ages 6-17 Years
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)
The purpose of this study was to evaluate dose response of the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children age 6-17 years.
- Trial name
- NCT02559570
- Testing
- LIN Dose A, LIN Dose B, LIN Dose C
- Where
- 62 sites in United States, Canada
- Volunteers
- 173 people
- Sponsor
- Forest Laboratories