[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ariel University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":103},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100647464","ibs-oriented-cded-versus-low-fodmap-diet-for-irritable-bowel-syndrome-100647464",false,"NCT07707635","IBS-Oriented CDED Versus Low FODMAP Diet for Irritable Bowel Syndrome","Open-Label, Randomized Controlled Study to Assess the Efficacy of a Modified Crohn's Disease Exclusion Diet (CDED) Versus Low FODMAP Diet for Managing Non-Constipation Irritable Bowel Syndrome","IBS-CDED","Inclusion Criteria:\n\n* Adults, men, and women (≥18 years) are diagnosed with IBS-D or IBS-M according to Rome IV criteria.\n* Moderate-to-severe symptoms (IBS-SSS score ≥175).\n* Stable use of any IBS-related medications for ≥6 weeks before study enrollment, except for antibiotics\n\nExclusion Criteria:\n\n* Coexisting GI diseases \\[e.g., Crohn's disease, ulcerative colitis, SIBO, celiac disease \\[positive transglutaminase (TTG) serology\\].\n* Disease that could explain or influence symptoms or GI function, including diabetes, thyroid disease \\[abnormal Thyroid-Stimulating Hormone (TSH)\\], and bariatric surgery.\n* Recent intestinal resection.\n* Pregnancy or breastfeeding.\n* Known food allergies.\n* Current active eating disorder\n* Participants already following a restrictive diet, including diets that overlap with the interventions in this study, will be excluded to prevent confounding effects on gut microbiota composition and gastrointestinal symptoms, and to ensure consistent baseline conditions. However, individuals who have discontinued such diets at least two to four weeks prior to enrollment may be eligible, allowing for a sufficient dietary washout period to minimize residual effects on the gut microbiota.\n* Currently under obesity management medication treatment.\n* Vegans\n* Use of antibiotics within the 4 weeks prior to enrollment or during the study period.\n* Abnormal hemoglobin levels (for women\\\u003C11.5 gr\u002Fdl, for men\\\u003C13 gr\u002Fdl)29\n* Baseline CRP≥5","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden. Recent evidence highlights the role of low-grade inflammation, impaired intestinal permeability and gut microbiota dysbiosis in the pathophysiology of non-constipated IBS (IBS with predominate diarrhea; IBS-D and mixed type IBS; IBS-M). Most patients report food-related symptom exacerbation, making dietary intervention a cornerstone of treatment. While the low-FODMAP diet (LFD) is widely used to reduce fermentable carbohydrates and alleviate symptoms, it may negatively affect microbial diversity and lacks anti-inflammatory effects. In contrast, the Crohn's Disease Exclusion Diet (CDED), developed for Crohn's disease, has demonstrated the ability to reduce intestinal inflammation, improve barrier function, and promote a favorable microbiota profile. These mechanisms may be relevant and beneficial in IBS, but have yet to be studied in this population.\n\nObjectives: To compare the efficacy of a modified CDED to the LFD for the treatment of non-constipated IBS symptoms, Hypothesis: A modified CDED will be at least as effective as the LFD in alleviating non-constipation IBS symptoms, stool consistency, quality of life, and psychological distress, while demonstrating superior effects on markers of low-grade inflammation, gut microbiota composition, and intestinal permeability.\n\nMethods: This is a single-center, open-label, randomized study to be conducted at the Gastroenterology Department of Sheba Medical Center. 136 adults diagnosed with Rome IV-defined IBS-D or IBS-M and an IBS Symptom Severity Score (IBS-SSS) ≥175 will be randomized 1:1 to receive either a modified CDED or the LFD for 6 weeks. Accounting for a 10% dropout rate, the total sample size will be 150.\n\nFollowing a 14-day screening period, eligible participants will undergo data collection at baseline, week 3 and week 6. Visit 1 (screening) will be conducted on-site; visits 2-4 will be remote. Participants will complete daily symptom diaries \\[Bristol Stool Form Scale (BSFS) and GI Visual Analogue Scale (VAS)\\], and weekly IBS-SSS. Validated questionnaires assessing psychological distress, somatization, extraintestinal symptoms, and quality of life will be administered at each time point.\n\nStool samples will be collected at baseline, week 3, and week 6. Fecal calprotectin (FC) and α1-Antitrypsin (A1AT) will be analyzed as markers of intestinal inflammation and permeability. Microbiota analysis will be conducted using 16S rRNA gene sequencing, with evaluation of microbial diversity, taxonomic shifts, and associations with clinical and biological outcomes.\n\nSignificance: This is the first study to evaluate the modified CDED as a dietary intervention for the treatment of IBS. It may offer a novel, inflammation-targeted alternative treatment for IBS.",[27],"Irritable Bowel Syndrome (IBS)",[29,30,31,32,33,34,35,36,37],"Crohn's Disease Exclusion Diet (CDED)","Low FODMAP Diet","Diet Therapy","Gut Microbiota","Intestinal Permeability","Fecal Calprotectin","Alpha-1 Antitrypsin","IBS-D","IBS-M","NOT_YET_RECRUITING","2026-07-12",{"date":41,"type":42},"2026-07-16","ACTUAL",{"date":44,"type":21},"2026-07-07",{"date":46,"type":21},"2028-12-31",{"name":48,"class":49},"Ariel University","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"100549230","nutritional-therapy-to-incretin-based-anti-obesity-medications-in-the-management-of-gastrointestinal-adverse-events-100549230","NCT06431308","Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events","Adjuvant Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events During the Up-titration Phase","Inclusion Criteria:\n\n* individuals aged ≥ 18 years\n* eligible to receive AOM \\[i.e., BMI ≥ 30 kg\u002Fm2 or ≥ 27 kg\u002Fm2 with at least one adiposity-related coexisting condition (e.g., diabetes or pre-diabetes, hypertension, dyslipidemia, obstructive sleep apnea, fatty liver, cardiovascular disease)\\]\n* who can read and speak Hebrew.\n\nExclusion Criteria:\n\n* Contraindications or precautious for treatment with Wegovy© or Mounjaro© \\[i.e., personal or family history of medullary thyroid cancer (MTC), personal history of multiple endocrine neoplasia type 2 (MEN2) syndrome, attempting conception, current pregnancy or breastfeeding\\]\n* previous bariatric surgery or endo-bariatric procedure\n* presence of chronic pancreatitis\n* treatment with AOM within a month before enrollment\n* patients with type 1 diabetes mellitus\n* patients who underwent other major GI surgery prior to medication treatment\n* patient with underlying GI disease \\[e.g., gastroparesis, celiac, Inflammatory Bowel Disease (IBD)\\]\n* a positive diagnosis of small-intestinal bacterial overgrowth (SIBO)\n* patients with active gastritis, gastroenteritis\n* chronic usage of promotility drugs or laxatives\n* patients with uncontrolled mental illness\n* significant cognitive deterioration\n* alcohol consumption exceeding 1 drink per day for women and 2 drinks per day for men .\n\nIn addition, participants who decide not to initiate or stop Wegovy© or Mounjaro© treatment for more than two consecutive injections for any reason or who undergo bariatric surgery or endoscopic sleeve gastroplasty during the study period will be excluded from the study",true,{"count":59,"type":21},120,[24],"The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms, treatment discontinuation rate, nutritional parameters (e.g., dietary intake and eating habits), anthropometric measures, functional parameters, and QOL during the initiation and up-titration phase of incretin-based Anti Obesity Medications (AOM) treatment in patients with overweight\u002Fobesity.\n\nThe nutrition intervention protocol will be developed based on literature review, focus groups with health care professionals, and patient interviews.\n\nA single-center pilot study will be performed at the Tel-Aviv Assuta Medical Center, among 10 patients who are about to initiate long-term weight management treatment with Wegovy© (semaglutide 2.4 mg), followed by a multi-center, parallel design open-label, RCT, which will be conducted at the Tel-Aviv Assuta Medical Center and Rabin Medical Center - Beilinson Hospital, in 120 patients who are about to initiate long-term weight management treatment with Wegovy© or Mounjaro© .\n\nThe intervention group will receive nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). The control group will receive the usual nutrition care for patients treated with AOM.\n\nPrimary outcomes (gastrointestinal symptom assessment) and secondary outcomes (incretin-based AOM discontinuation rate, nutritional parameters, anthropometrics, functional parameters and QOL) will be evaluated by interviews, questionnaires and measurements at baseline, at the end of Wegovy© or Mounjaro© titration phase \\[20 weeks (T1)\\] and weekly during the study period (for GI symptoms assessment).",[63],"Obesity; Drug","RECRUITING","2025-04-21",{"date":67,"type":42},"2025-04-24",{"date":69,"type":42},"2025-01-30",{"date":71,"type":21},"2026-03-30",{"name":48,"class":49},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100560309","evaluating-family--community-based-interventions-to-improve-treatment-adherence-in-metabolic-health-among-negev-bedouins-efit-bed-100560309","NCT06575465","Evaluating Family & Community-Based Interventions to Improve Treatment Adherence in Metabolic Health Among Negev Bedouins (EFIT-BED)","Examining the Effectiveness of Family and Community-Based Intervention Programs to Improve Treatment Adherence for Overweight, Obesity, Prediabetes, Metabolic Syndrome, and Type 2 Diabetes in the Bedouin Community in the Negev","EFIT-BED","Inclusion Criteria:\n\n* Bedouin men and women aged 18 and above\n* Diagnosed with overweight, obesity, metabolic syndrome, prediabetes, or type 2 diabetes\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* Individuals with other chronic diseases that might interfere with the study\n* Pregnant or lactating women\n* Individuals unable to provide informed consent",{"count":82,"type":21},170,[24],"Background:\n\nThe Bedouin community in the Negev faces high rates of type 2 diabetes, low treatment adherence, and increased disease complications. Transition to urban living and changing dietary patterns have exacerbated these issues. Current interventions often overlook the potential of culturally tailored approaches leveraging kinship ties and community resources. This study seeks to address these gaps by examining the impact of a family-centered intervention program.\n\nObjectives:\n\nPrimary: Assess the effect of community intervention on Mediterranean diet adherence.\n\nSecondary: Evaluate changes in fasting glucose, HbA1c, lipid profiles, BMI, physical activity, and quality of life.\n\nMethodology:\n\nStudy Design: Controlled community intervention trial with two groups (intervention and control).\n\nParticipants: 170 Bedouin adults diagnosed with overweight, obesity, metabolic syndrome, prediabetes, or type 2 diabetes.\n\nIntervention: 10 sessions over 12 months focusing on nutrition, physical activity, and behavioral changes, tailored to cultural norms.\n\nControl: Routine care without added intervention. Outcome Measures: Lab tests (HbA1c, lipid profiles), anthropometric measures, Mediterranean diet adherence, physical activity, quality of life, and social belonging.\n\nRecruitment and Data Collection:\n\nParticipants will be recruited via Clalit clinics in Rahat, with the support of local community leaders. Data will be collected through medical records, questionnaires, and physical assessments at baseline, 6, and 12 months.\n\nData Analysis:\n\nStatistical analysis will be performed using SAS\u002FSPSS, employing ANOVA, Chi-square tests, and regression models for outcome prediction.\n\nEthical Considerations:\n\nParticipants' privacy will be ensured through coded data storage. The study will comply with Helsinki guidelines, and participants can withdraw at any time.\n\nConclusion:\n\nThis study aims to provide culturally tailored interventions to improve health outcomes in the Bedouin community, potentially serving as a model for similar minority groups globally.",[86],"Community-Based Participatory Research",[88,89,90,91,92,93],"Type 2 Diabetes Mellitus","Obesity","Community based participatory research","Health promotion","Clinical trial","Prediabetes","2025-01-27",{"date":96,"type":42},"2025-01-28",{"date":98,"type":42},"2024-09-01",{"date":100,"type":21},"2026-05-31",{"name":48,"class":49},1,""]