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Intestinal Disease clinical trials

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NCT ID: NCT06295575 Completed - Clinical trials for Congenital Heart Disease

Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora.

NCT ID: NCT05234515 Completed - Clinical trials for Surgical Site Infection

Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure

BUGS-IN-IF
Start date: January 14, 2022
Phase:
Study type: Observational

This is a prospective observational study of patients undergoing planned surgery for intestinal failure. The aims of the study are: - To prospectively characterise preoperative bacterial populations amongst patients undergoing surgery for intestinal failure - To examine the relationship between preoperative bacteriology and surgical site infection (SSI) in this patient group - To investigate the effect of surgery and surgical site infection on generic and wound specific quality of life measures

NCT ID: NCT04982302 Completed - Periodontitis Clinical Trials

Gut Microbial Changes After Periodontal Treatment

Start date: May 1, 2021
Phase:
Study type: Observational

Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that non-surgical periodontal treatment may reduce bacterial alpha diversity in stool samples. Fifty patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and 3 months after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.

NCT ID: NCT04573959 Completed - Crohn Disease Clinical Trials

Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

To validate an updated version of CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.

NCT ID: NCT04263818 Completed - Colonic Diseases Clinical Trials

Endoscopist and Endoscope Motions During Colonoscopy

ScopeGuide
Start date: June 5, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.

NCT ID: NCT03817645 Completed - Clinical trials for Irritable Bowel Syndrome

Panaceo "MED" for IBS (Irritable Bowel Syndrome)

PCeo-17
Start date: March 9, 2018
Phase: N/A
Study type: Interventional

Zeolite clinoptilolite is a volcanic mineral from the group of zeolites. The porous structure is associated with a large inner surface. Due to the anionic framework charge, ions (e.g., Pb^2+) can be absorbed or exchanged. The specific Panaceo PMA zeolite is approved as a class IIa medical device for the repair of the intestine inner lining. It is CE certified and complies with the relevant European Union regulations in terms of safety and effectiveness. Zeolite is known for its absorbing properties. Because of these properties and the results of several human studies, it warrants the investigation of possible effects on specific indications in human medicine, e.g. irritable bowel syndrome. The diagnosis "irritable bowel syndrome (IBS)" is according to the ROME Foundation, an US medical society. IBS is a disorder with dysfunction of the bowels, a latent inflammation is discussed. The present study aims to evaluate the following effects in patients with IBS: - Primary endpoint: effect on the symptoms of IBS. - Secondary endpoint: intestinal wall permeability, integrity of the tight junctions as measured by the change in zonulin concentration in the stool. - Further endpoints: - Inflammation parameters and anti-inflammatory laboratory parameters. - Biodiversity of the gastrointestinal microbiome. - histamine-associated parameters. - Constipation as a possible side effect. For this purpose, a double-blind randomized controlled trial (RCT) is realized prospectively in a monocentric outpatient-controlled study. The subjects take the test compound daily (verum, reference substance) for 12 weeks and document the intake of the study-substance, intake of medications, stool-frequency and consistency. They receive "before" and "after" the intervention phase a blood and stool analysis for the determination of parameters for intestinal wall integrity (zonulin) inflammation (hsCRP, interleukin-10, calprotectin), histamine metabolism, microbiome diversity. The pilot study is realized ahead of the detailed planning of a later main study.

NCT ID: NCT03723447 Completed - Pain Clinical Trials

Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)

TINGLE
Start date: October 23, 2018
Phase: Phase 4
Study type: Interventional

Traditionally, opioids are heavily utilized in treating postoperative pain but they are associated with numerous side effects. The use of the transversus abdominis plane (TAP) blocks have become standard practice to extend the post-operative analgesic window and limit opioid use. A new liposomal-depo formulation of bupivacaine (Exparel) has gained popularity as a long-lasting TAP block medication, but has not been studied in a well-powered clinical trial specifically in colorectal patients nor compared to a bupivacaine/steroid mixture which may offer similar effects. We conduct a prospective randomized prospective randomized study of patients undergoing major laparoscopic colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus liposomal bupivacaine.

NCT ID: NCT03559543 Completed - Clinical trials for Gastrointestinal Neoplasms

Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma

Start date: October 25, 2018
Phase: Phase 2
Study type: Interventional

The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Laboratorios Catalysis S. L., comes in the form of single-dose vials of 30 ml. It will be used at a rate of 60 ml daily (1 vial every 12 hours). Our main objective is To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Our hypothesis is that the administration of the nutritional supplement Ocoxin®-Viusid® it is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients.

NCT ID: NCT03543540 Completed - Celiac Disease Clinical Trials

Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

Start date: May 1, 2018
Phase: Phase 1
Study type: Interventional

A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).

NCT ID: NCT03509220 Completed - Clinical trials for Gastrointestinal Disease

Safety and Efficacy of PBK-1701TC for Bowel Cleansing Before Colonoscopy

Start date: April 11, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy, safety and tolerability of PBK-1701TC for bowel cleansing before colonoscopy. Half the participants will receive PBK-1701TC and while the other will receive standard oral preparation.