Clinical trials: GI Tract Disorders
- Condition GI Tract Disorders
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Autism Spectrum Disorder, Autism
Autism Spectrum Disorder (ASD) Neurodevelopmental Disorder With Issues Social Behavior, Communication Issues, GI Dysfunction. Study is Multimodal Interventions Targeting These Pathways With cSVF, Stored MSCs, FMT and Diet Modification. Role of Autoimmunity, Gut-brain Issues, & Issues Examined.
Autism spectrum disorder (ASD) is a neurodevelopmental condition with core deficits in social communication and behavior, often accompanied by gastrointestinal (GI) and metabolic dysfunction.
- Conditions
- Autism Spectrum Disorder, Autism, Autism Spectral Disorder
- Trial name
- GARM-Autism (NCT07546942)
- Testing
- Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells, Fecal Biomicrome Transplantation (FMT), Ketogenic RESET Diet Protocol
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Black Tie Medical, Inc.
Urea Cycle Disorders
Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders
This clinical food study aims to explore the effect of KB195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (UCDs).
- Trial name
- NCT03797131
- Testing
- KB195 (a novel mixture of oligosaccharides)
- Where
- Switzerland
- Volunteers
- 4 people
- Sponsor
- Kaleido Biosciences
Graft Vs Host Disease, Gastrointestinal Graft-Versus-Host Disease
Randomized Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal GVHD
Patients with gastrointestinal graft-vs.-host disease are randomized to oral beclomethasone dipropionate (BDP) 8 mg/day or identical placebo tablets for 50 days, along with a 10-day induction course of prednisone.
- Trial name
- NCT00233896
- Testing
- Oral beclomethasone dipropionate (drug)
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Enteron Pharmaceuticals
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.
Gastrointestinal Disease, Inflammatory Bowel Disease (IBD)
Elemental 028 Extra Case Studies
Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to…
- Conditions
- Gastrointestinal Disease, Inflammatory Bowel Disease (IBD), Short Bowel, Malabsorption
- Trial name
- E028E (NCT06877923)
- Testing
- Elemental 028 Extra
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Nutricia UK Ltd
Gut Health, Gastrointestinal Diseases
Improved Gut Health Outcomes Associated With Probiotics Fortified With Hydrolyzed Whey Protein in Infant Formula
The goal of this interventional clinical trial is to test the effectiveness of improving gut health in terms of frequency of bowel movements in newly born infants fed with Feihe investigational formula product containing…
- Trial name
- NCT06159088
- Testing
- Feihe Investigational Formula, Control Formula, Breastfeeding
- Where
- 3 sites in China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Metastatic Sarcoma, Esophageal Cancer
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to…
- Conditions
- Metastatic Sarcoma, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer
- Trial name
- PHANTOM (NCT06298916)
- Testing
- 64Cu-LNTH-1363S
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Lantheus Medical Imaging
Autism Spectrum Disorder, Gastrointestinal Dysfunction
ASC - Autism Study
The ASC - Autism Pilot Study is a single center randomized open dose titrating phase I clinical intervention pilot trial with the aim of investigating safety and treatment effect of an allogeneic adipose tissue derived…
- Conditions
- Autism Spectrum Disorder, Gastrointestinal Dysfunction, Leaky Gut Syndrome, Mesenchymal Stromal Cells
- Trial name
- NCT05602116
- Testing
- Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Cell to Cure ApS
Healthy Term Infants
The Combiotic-Study
The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in…
- Trial name
- GOLFIII (NCT02221687)
- Testing
- Synbiotic formula, Control formula
- Where
- 25 sites in France
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Colitis, Ulcerative
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to < 12 years…
- Trial name
- ELEVATE-UCkids (NCT07470879)
- Testing
- Etrasimod
- Where
- 46 sites in United States, Australia and 8 more
- Volunteers
- 24 people
- Sponsor
- Pfizer
Healthy Young Adults
Exploring Wellbeing Outcomes in Adolescents Using Bifidobacterium Longum, 1714™
The purpose of this study is to evaluate changes in self-reported wellbeing outcomes in adolescents. Bifidobacterium longum, 1714™ has previously been associated with beneficial effects on stress-related outcomes, sleep quality…
- Trial name
- NCT07752342
- Testing
- Bifidobacterium longum, 1714™
- Where
- United Kingdom
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Novonesis
Metabolic Syndrome
Effects of Probiotics on Metabolic Syndrome ,Intestinal Microflora and SCFA.
The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC.
- Trial name
- NCT06183801
- Testing
- Probiotics 1, Probiotics 2, Probiotics 3
- Where
- Taiwan
- Volunteers
- 82 people
- Sponsor
- Glac Biotech Co., Ltd
Functional Gastrointestinal Disorders (FGIDs), Weight Loss
Effects of Multi-strain Bacillus Spore Probiotics on Growth, Digestive Function, and Gut Microbiota in Cesarean-Delivered Neonates
Infants born by cesarean section commonly show early weight loss and slower recovery of birth weight, together with characteristic patterns of gut microbiota dysbiosis marked by reduced Bifidobacterium and Bacteroides and…
- Trial name
- NCT07320287
- Testing
- RO water, LiveSpo PREG-MOM, LiveSpo CONSY
- Where
- Vietnam
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Anabio R&D
Premature Infant
Effect of a Mixture of New Probiotic Strains in Preterm Infants
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0…
- Trial name
- PREBIOMA (NCT03701906)
- Testing
- Lactobacillus PS11603 & Bifidobacterium PS10402
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL
Premature Birth of Newborn
Oral Formulation of Insulin for Preterm Infants
The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.
- Trial name
- NCT01093638
- Testing
- Oral Formulation of Insulin
- Where
- Israel
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Elgan Pharma Ltd.
Acne Vulgaris, Acneiform Eruptions
The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne
The purpose of this study is to evaluates how probiotics and dietary supplementation with an herbal powder can shift the gut microbiome in those with non-cystic acne vulgaris.
- Conditions
- Acne Vulgaris, Acneiform Eruptions, Skin Diseases, Sebaceous Gland Diseases
- Trial name
- NCT05919810
- Testing
- Probiotic, Oral herbal powder supplement
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Integrative Skin Science and Research
Microbiota, Eczema
Infant Restore: Efficacy of Microbiome Analysis and Education
The goal of this clinical trial is to learn if a microbiome analysis, education, and recommendation program can improve gut health, reduce future health risks, and empower parents in their children's health in infants aged 0-3…
- Conditions
- Microbiota, Eczema, Microbiome, Gut Microbiome
- Trial name
- NCT06424691
- Testing
- Tailored Recommendations, Consult Call, Email Series
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Seeding Inc
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.
Breast Cancer, Prostate Cancer
Tempus Priority Study: A Pan-tumor Observational Study
Observational study that will be collecting clinical and molecular health information from cancer patients who have received comprehensive genomic profiling and meet the specific eligibility criteria outlined for each cohort with…
- Conditions
- Breast Cancer, Prostate Cancer, Bladder Cancer, Lung Cancer
- Trial name
- NCT05179824
- Testing
- Observation
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Tempus AI
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