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Campylobacter Infections clinical trials

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NCT ID: NCT05500417 Active, not recruiting - Clinical trials for Campylobacter Infection

Safety and Immunogenicity of CJCV2 With and Without ALFQ

Start date: September 13, 2022
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, dose-escalating, outpatient trial in a total of approximately 60 subjects, assigned to 3 cohorts (20 subjects per cohort). Each subject will receive one of three intramuscular (IM) vaccinations, spaced 28 days apart, of Campylobacter jejuni Conjugate Vaccine (CJCV2) with or without a fixed dose of the adjuvant Army Liposome Formulation containing QS-21 (ALFQ)(200 mcg 3D-PHAD, 100 mcg QS-21). Three doses (1 ug, 3 ug and 10 ug) of CJCV2 will be evaluated. The first six participants at each dose will be sentinels and randomized in a 1:1 blinded fashion to receive CJCV2 with or without ALFQ. The primary objective is to evaluate the safety of the three different doses of IM injection of CJCV2 with and without ALFQ. The study hypothesis is that the CJCV2 vaccine alone and CJCV2 with ALFQ adjuvant will be safe and that the CJCV2 alone will be immunogenic, with immunogenicity enhanced through the use of the adjuvant ALFQ.

NCT ID: NCT04182490 Completed - Clinical trials for Campylobacter Infections

LMN-101 in a Campylobacter Human Challenge Model

Start date: February 21, 2022
Phase: Phase 2
Study type: Interventional

Randomized, double-blind, placebo-controlled, single dose regimen study of LMN-101 followed by Campylobacter jejuni challenge. Subjects will initially, after documentation of informed consent, begin taking their assigned LMN-101 or placebo regimen three times daily. After two days, subjects will receive the C. jejuni challenge inoculum. Subjects will begin an appropriate antibiotic course upon meeting early treatment criteria or 144 hours following C. jejuni challenge, whichever is earlier. Subjects will be allowed to leave the clinical research facility 3 days after antibiotics, when all symptoms have resolved or are resolving, and have had ≥ 2 consecutive stool cultures ≥ 12 hours apart negative for C. jejuni and are afebrile > 24 hours prior to release and off antipyretics within 24 hours of discharge. Subjects will continue taking their LMN-101 or placebo regimen three times daily for a total of 14 days. Subjects will be provided a diary card/memory aid and thermometer for at-home monitoring of solicited adverse events through Day 24. Subjects will be seen at research facility for protocol-specified evaluations and will also be contacted by telephone 6 months after challenge.

NCT ID: NCT03683667 Completed - Stunting Clinical Trials

Protein Plus: Improving Infant Growth Through Diet and Enteric Health

JiVitA-6
Start date: September 23, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This cluster-randomized controlled trial is designed to address linear growth faltering in 6-12-mo-old Bangladesh infants through a proof-of-concept package of interventions to a) increase intake of high quality protein and b) control enteric pathogens.

NCT ID: NCT03266068 Completed - Clinical trials for Irritable Bowel Syndrome

Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders

Start date: September 2016
Phase:
Study type: Observational

Some people develop chronic abdominal pain with diarrhea or constipation after an episode of acute bacterial gastroenteritis. These symptoms can be consistent with post-infectious irritable bowel syndrome (IBS) and can last long after the acute infection is over. The exact reason why certain individuals develop these symptoms whereas others don't is not exactly clear. The researchers are studying changes in gastrointestinal permeability (movement of contents across the lining of the intestine) and transit (movement of food through the gastrointestinal tract). The researchers are also studying if there are any genetic risk factors that are associated with development of this disorder.

NCT ID: NCT03223077 Recruiting - Clinical trials for Irritable Bowel Syndrome

Mucosal and Microbiota Changes During Acute Campylobacteriosis

Start date: October 31, 2014
Phase:
Study type: Observational

Gastrointestinal (GI) infection with Campylobacter causes inflammation in the bowel and can change bacteria in the gut. Certain individuals with Campylobacter infection are also known to develop chronic bowel problems such as Irritable Bowel Syndrome (IBS). The researchers are doing this study to understand if changes in gut bacteria and gut mucosal lining during an acute infection can help identify individuals who might be at risk for developing problems in the future.

NCT ID: NCT02884752 Completed - Clinical trials for Bone Diseases, Infectious

Retrospective Study of Bone Infection Due to Campylobacter Spp

CAMPYLO
Start date: December 2014
Phase: N/A
Study type: Observational

Only 24 cases of Campylobacter bone and joint infection (BJI) have been reported worldwide between 1955 and 2008. Between 2010 and 2012, 7 cases were observed in two University hospitals in France. This increasing number of cases raises several issues. Are they the consequences of better detections and reporting, or are they reflecting any epidemiologic changes? For answering these questions, we performed a 10 year (2002-2012) retrospective multicenter (6 centers) study on BJI (native and implanted joints) due to Campylobacter species.

NCT ID: NCT02280044 Completed - Diarrhea Clinical Trials

Efficacy of Rifaximin in Preventing Campylobacteriosis

Start date: October 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C. jejuni.

NCT ID: NCT02105714 Completed - Schistosomiasis Clinical Trials

Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders

NIDIAGDigest
Start date: July 2014
Phase: N/A
Study type: Observational

NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system for delivering primary health care in resource-constrained settings. NIDIAG will investigate three clinical syndromes, namely (i) persistent digestive disorders, (ii) persistent fever and (iii) neurological disorders, due to neglected tropical diseases (NTDs). The current study focuses on persistent digestive disorders, which are defined as diarrhoea or abdominal pain that last for at least 2 weeks. While acute diarrhoea has been studied globally, few research activities have focused on the epidemiology, diagnosis and treatment of long-lasting diarrhoeal episodes (2 weeks and longer) in the tropics. The spectrum of possibly involved pathogens includes more than 30 bacterial, parasitic and viral infectious agents. This lack of data may be explained by the fact that people suffering from NTDs might only seek care at a late stage of the disease. Furthermore, health systems in affected regions are often weak and their primary health-care centres are often under-staffed and lack essential diagnostic equipment. The hypothesis of this study is that development of an evidence-based syndromic approach can lead to better diagnosis and management of NTDs in patients with persistent digestive disorders. The study will be carried out in two West African countries (Côte d'Ivoire and Mali) and in two Asian countries (Indonesia and Nepal). The study will follow a "case-control" design and patients and controls will be prospectively enrolled. In order to address the knowledge gaps, three specific objectives will be pursued. First, the contribution of NTDs to the 'persistent digestive disorders syndrome' will be assessed. Second, the value of clinical features and rapid diagnostic tests (RDTs) for the diagnosis of target NTDs that give rise to persistent digestive disorders will be determined. Third, the clinical response to standard empiric and targeted treatment of several NTDs in patients with persistent digestive disorders will be evaluated. These objectives will provide a long-term benefit for the communities by improving the clinical decision-making process for the target NTDs and thus, better diagnostic work-up and patient management can be achieved in the study countries and other similar resource-constrained countries

NCT ID: NCT02067676 Completed - Clinical trials for Campylobacter Infection

Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea

CJCV1-01
Start date: April 21, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety of increasing doses of a potential vaccine against Campylobacter with and without Alhydrogel®, an aluminum hydroxide adjuvant. This study will also assess immune responses induced by the vaccine.

NCT ID: NCT02040922 Active, not recruiting - Clinical trials for Irritable Bowel Syndrome

Campylobacter Enteritis and Post-Infective Bowel Dysfunction (PI-BD): Role of Antibiotics and Microbiota

CERAMIC
Start date: January 2013
Phase: N/A
Study type: Observational

The principal research objective is to determine the impact of antibiotic use on the risk of developing long term bowel symptoms after infection with the germ Campylobacter.