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Intestinal Diseases clinical trials

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NCT ID: NCT03487926 Active, not recruiting - Clinical trials for Inflammatory Bowel Diseases

Microglial Activation in Inflammatory Bowel Disease

Start date: September 14, 2022
Phase:
Study type: Observational

The purpose of this study is to monitor microglial activation in participants with inflammatory bowel disease (IBD) and investigate the relationship that exists between these patients and their risk of acquiring major depressive episodes (MDE). Patients with both IBD and MDE will be subsequently approached to participate in the study.

NCT ID: NCT03426826 Active, not recruiting - Clinical trials for Gastro-Intestinal Disorder

The Gut-Brain Study

Start date: August 15, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out if transplant of fecal matter (stool), also known as fecal microbiota transplantation (FMT), from a healthy person into the intestines of children and young adults with Autism Spectrum Disorder (ASD). For this study children between the ages of 5-17years will be recruited over 2 years. Children will be recruited who receive an ASD diagnosis using the gold-standard Autism Diagnosis Observation Schedule -2 (ADOS-2) using module 1, 2 or 3 (none, limited or no moderate expressive language). Children diagnosed with these modules of the ADOS-2 may be at greater risk for GI disorders and rigid-compulsive behaviors. Additional assessment of rigid-compulsive behaviors and social communication will be done using the Repetitive Behavioral Scales-Revised (RBS-R) and Social Responsiveness Scale-2 (SRS-2), respectively. KBIT (the Kaufman Brief Intelligence Test) is used at baseline to obtain patient IQ. Total evaluation time is approximately 90 minutes. Following baseline symptom evaluation, a medical exam will be performed to determine whether each child is expressing specific GI symptoms. In addition, parents will fill out the Questionnaire for Pediatric Gastrointestinal Symptoms- Rome III (QPGS-III). Once an ASD diagnosis is confirmed, FMT treatment will be initiated, which typically occurs within 4-6 weeks of the initial diagnosis. Half 50% of the children (n=5) will receive the equivalent of 50 g of stools from a healthy donor into the jejunum through upper endoscopy and the other 50% off children (n=5) will receive Saline solution as Placebo control through upper endoscopy. Subjects will have a total of 5 visits within 24 weeks including phone call follow up on Day 7 after FMT.

NCT ID: NCT03397108 Active, not recruiting - Ulcerative Colitis Clinical Trials

Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease

Start date: July 4, 2017
Phase:
Study type: Observational

Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications. Sometimes, concerns about transfer of drugs to infants via breast milk lead the mothers to either avoid breastfeeding or stop their medication. Inflammatory Bowel Disease (IBD) is a chronic condition that is marked by an abnormal response of the body's immune system, and high levels of certain proteins that cause inflammation (Cytokines like Tumor Necrosis Factor-alpha or TNFα). A group of drugs called "biologics" target and stop these proteins from causing inflammation, and have been successfully used to treat this condition. Inflammatory proteins may be present in breast milk of healthy women in variable levels, and may play a role in development of infant's brain and immune system. This study is being conducted to investigate: - Concentration of some of the inflammatory proteins in breast milk of mothers with IBD and healthy controls - Interaction between these proteins and biologics in breast milk of women with IBD - Potential role of these proteins (and their interaction with biologics) on development of infant learning and memory function It has been presumed that concentrations of TNFα and some other cytokines are higher in breast milk of women with IBD, and the biologics can normalize these high levels. Due to precautions for COVID-19, the study now consists of only two mandatory study visits and two optional study visits. The mandatory visits include two home visits in the first 4 months postpartum to complete a participant questionnaire and collect a small sample of breast milk at each visit. The optional study visits consist of two visits at the Hospital for Sick Children for evaluation of learning and memory function of the infant at the ages of 12 and 18 months. Additionally, mothers will be required to complete for their infant subscales of The Ages and Stages Questionnaires®, Third Edition (ASQ®-3) either in person or over the telephone at the ages of 12 months and 18 months.

NCT ID: NCT03299413 Active, not recruiting - Clinical trials for Inflammatory Bowel Diseases

Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease

Start date: June 5, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Scientists hypothesize that directly or parentally injecting Mesenchymal stem cells (MSCs) to affected areas will have a positive impact through reducing or abolishing intestinal inflammation in part via inhibition of neutrophil Myeloperoxidase (MPOx) activity. Inhibiting MPOx should modify disease progression as well as reduce colitis associated cancer risk.

NCT ID: NCT03266484 Active, not recruiting - Ulcerative Colitis Clinical Trials

Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease

Start date: November 13, 2017
Phase: N/A
Study type: Interventional

The study is proposed as a single-site randomized double-blind placebo-controlled trial requiring 4 study visits, where two of the visits are combined with their appointment for routine clinical care. The study population will consist of patients with quiescent CD and UC and IBD-unspecified recruited from the Massachusetts General Hospital Crohn's and Colitis center. All eligible subjects will have a confirmed diagnosis of CD, UC, or IBD-unspecified according to accepted clinical, endoscopic, radiologic, and histologic criteria. Eligible patients will be contacted at the time of their routinely scheduled office visit and consented for the study. Self-report and review of medical records will be used to obtain detailed information regarding their disease on an intake questionnaire completed by a research study coordinator. The study is proposed as a 12-week double-blind randomized controlled trial of the probiotic supplement compared to placebo. We propose to examine the effect of a specific probiotic supplement on the changes in the gut microbiome, serum metabolomic profile, and fatigue symptoms in patients with quiescent IBD. Within 2 weeks of screening, eligible patients will be invited to visit MGH for a baseline visit. The patient will receive either the probiotic supplement or placebo for 4 weeks. The first follow up visit will be at week 4 to check for adverse events on study treatment, to check accountability of probiotics/placebo, and to complete the set of questionnaires. Also, subjects will receive probiotic/placebo samples for the remaining 8 weeks of treatment. At week 8, subjects will receive a phone call from a study research coordinator to check in with probiotics/placebo intake for treatment compliance and accountability records, and to complete the set of questionnaires ascertaining subjective symptoms. Last study visit will be at week 12 which is often combined with a regular office appointment. Subject will provide serum blood and stool sample, as well as complete the set of questionnaires.

NCT ID: NCT03220841 Active, not recruiting - Crohn Disease Clinical Trials

Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

STRIDENT
Start date: October 9, 2017
Phase: Phase 4
Study type: Interventional

Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.

NCT ID: NCT03012048 Active, not recruiting - Clinical trials for Environmental Exposure

Effectiveness of Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in South Africa

Start date: June 2016
Phase: N/A
Study type: Interventional

This project is a community-based randomized controlled trial designed to test the effectiveness of two point-of-use water treatment technologies to improve clean drinking water access, reduce enteropathogen burden, and improve child growth among children in Limpopo, South Africa.

NCT ID: NCT02849821 Active, not recruiting - Clinical trials for Inflammatory Bowel Disease

The Altitude Inflammatory Bowel Disease Study

Start date: May 2014
Phase: N/A
Study type: Interventional

This is a prospective, controlled and observational study. Participants underwent a 3-hour exposure to hypoxic conditions simulating an altitude of 4,000 meters above sea level (m.a.s.l.) in a hypobaric pressure chamber. Clinical parameters, as well as blood and stool samples and biopsies from the sigmoid colon (by sigmoidoscopy) are collected at subsequent time points. The investigators goal is to evaluate if a 3-hour stay at high altitude (4, 000 m) can alter disease activity and can modulate a pro inflammatory reaction.

NCT ID: NCT02571881 Active, not recruiting - Pain, Postoperative Clinical Trials

Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section

oksisektio
Start date: October 2012
Phase: Phase 4
Study type: Interventional

Constipation is common in pregnant women. Surgery, anaesthesia and opioid analgesics may further impair bowel function. The aim of the present study was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients undergoing caesarean section.

NCT ID: NCT02389075 Active, not recruiting - Clinical trials for Ankylosing Spondylitis (AS)

The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis

Start date: March 2015
Phase:
Study type: Observational

This study plans to learn more about the relationship between systemic autoimmune disease, such as inflammatory bowel disease and ankylosing spondyloarthritis, bacteria in the colon, and the changes in colon tissue.