Clinical Trials Logo
  1. Home
  2. Irritable Bowel Syndrome
  3. NCT03824821
  4. Details
NCT03824821 Clinical Trial

Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire

Irritable Bowel Syndrome Clinical Trial

— IBSQUtrition  

Official title:
Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03824821
Other study ID # 18/06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 22, 2018
Est. completion date May 31, 2018

Study information
Verified date January 2019
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a cross-sectional observational study design that aimed to include 2000 IBS patients. We used several validated questionnaires, to assess IBS characteristics (such as subtype, severity), psychological features (QoL, anxiety and depression) and assess nutritional triggers.

Subjects filled in the questionnaire online, and was spread across the Netherlands.

Recruitment information / eligibility
Status Completed
Enrollment 2076
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- IBS-like symptoms

Exclusion Criteria:

- younger than 18 years

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
Netherlands Wageningen University & Research Wageningen

Sponsors (10)
Lead Sponsor Collaborator
Wageningen University Bioiberica, Darling, Ingredia, Naturex, Netherlands: Ministry of Health, Welfare and Sports, Nexira, Roquette Freres, Wecare, Winclove

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary IBS subtype Assessed using the Validated Bristol stool chart 1 day (once )
Primary IBS severity Assessed by the validated Symptom severity scale (IBS-SSS), rangeing from 0 - 500; 0 very low and 500 very severe case 1 day (once )
Primary Nutrition questionnaire We composed a questionnaire containing 44 identified nutritional triggers from literature, and asked subjects if they had (0, no complaints), 1 little complaints, 2 severe complaints, after eating that product. 1 day (once )
Primary Birmingham symptom questionnaire Validated questionnaire that assesses symptoms for three domains: pain, diarrhoea and constipation 1 day (once )
Secondary Irritable bowel syndrome Quality of Life questionnaire We used the validated IBS-QOL which asked 44 questions about quality of life related to IBS. Score ranged from 0 - 100: 100 indicating a very high quality of life, 0 indicating a very poor quality of life 1 day (once )
Secondary Hospital Anxiety and Depression Score (HADS) We used the validated HADS questionnaire to assess anxiety and depression in IBS patients. This questionnaire gives 2 scores: one for anxiety and depression. Scores range from 0-21, a score above 8 can be referred to as being a case for having anxiety or depression 1 day (once )
Secondary treatment options currently used We self-composed a questionnaire to assess what type of treatments patients already used, and what their perceived effect was. 1 day (once )
Secondary Rome IV criteria Validated questions to check whether a subject fits within the profile of IBS 1 day (once )
See also
  Status Clinical Trial Phase
Completed NCT03720314 - Microbiota Profiling in IBS
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT05213910 - Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains N/A
Recruiting NCT05985018 - Traditional Dietary Advice Vs. Mediterranean Diet in IBS N/A
Completed NCT04486469 - Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study. N/A
Completed NCT06407609 - Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS N/A
Completed NCT04656730 - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas Phase 4
Completed NCT04145856 - Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico Phase 4
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Active, not recruiting NCT03586622 - One Year Home Monitoring and Treatment of IBS Patients N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Not yet recruiting NCT05157867 - In Vivo Effects of Amylase Trypsin Inhibitors N/A
Not yet recruiting NCT05100719 - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION) N/A
Recruiting NCT05001997 - Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome N/A
Recruiting NCT02953171 - Probiotics in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT02977975 - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome N/A
Completed NCT03266068 - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed NCT02980406 - The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level N/A
Completed NCT03318614 - Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster Phase 2/Phase 3