- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05475314
Effect of Postbiotic Product on Colonic Barriers in IBS
A Postbiotic Fermented Oat Gruel May Have a Beneficial Effect on the Colonic Mucosal Barrier in Patients With Irritable Bowel Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A single-blinded, randomised experimental study was conducted. Potential participants were screened based on the inclusion and exclusion criteria during telephone interviews. As the patients were their own controls, self-reported allergy was not an exclusion criterion as long as both interventions were carried out during unchanged allergic exposure.
Patients were then randomly allocated to one of two study arms: Referm® or thickened water (Thick-it ®, commercially available; Kent Precision Foods Group, Inc., Muscatine, IA, USA) as placebo. The patients underwent sigmoidoscopy with biopsies obtained from the distal colon at baseline and after 14 days of intervention with ReFerm® or placebo enema twice a day. The enema was administered rectally, in the left side position, and retained for as long as possible (at least 10 min) both in the left-sided and supine body position to activate retrograde peristalsis. To assess clinical improvement of symptoms, questionnaires were completed twice: before and after the intervention. During the 14 days of the intervention, the patients completed daily questionnaires. To improve compliance with the study intervention, the patients were given a check-up call by a principal investigator (OBe) twice per week during the intervention period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Linköping, Sweden, 58185
- Linköping University Hospital, Linköping, Sweden
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Confirmed IBS-D or IBS-M according to Rome IV criteria
- Moderate to severe IBS according to IBS-SSS score (≥175p)
- Age 18-70 years
- Fluency in written and spoken Swedish language
Exclusion Criteria:
- Organic gastrointestinal disease
- Previous major gastrointestinal operation (apart from appendectomy and cholecystectomy)
- Psychiatric disease (bipolar disease, schizophrenia)
- NSAID intake less than 2 weeks prior to endoscopy
- Self-reported pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ReFerm(R); fermented oat gruel
ReFerm® is manufactured by the fermentation of an oat gruel with L. plantarum 299v.
The product is tested for pH and colony-forming units (CFU) of Enterobacteriaceae, yeasts/moulds, and L. plantarum 299v.
The pH must be < 4.0, the CFU of Enterobacteriaceae and yeasts/moulds must be < 100/mL, and the CFU for L. plantarum 299v must be > 10E+08 immediately after completion of fermentation.
The energy content of 100 mL ReFerm® is 58 kcal (240 kJ), from 1.6 g protein, 9.8 g carbohydrate, and 0.9 g fat.
Each ReFerm® package contained 250 ml
|
Enemas of approx 250 mL twice daily
Other Names:
|
Placebo Comparator: Thick-it(R); thickened water
Thick-it ® mildly thick, Kent Precision Foods Group, Inc.; commercially available) was chosen as a placebo to mimic the viscosity.
This product contains artesian mineral water and ≤ 2% xanthan gum, calcium chloride, malic acid, potassium benzoate, potassium sorbate (to preserve freshness), sodium hexametaphosphate, and disodium EDTA.
The energy content of 237 mL Thick-it ® (one package) was 5 kcal (21 kJ) from 0 g protein, 1 g carbohydrate, and 0 g fat
|
Enemas of approx 250 mL twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intestinal permeability
Time Frame: 14 days
|
Basic Science. Mucosal permeability change (transcellular (amount of HRP (fmol/mL) and paracellular (amount of FITC (pM)), before and after treatment using an Ussing chamber with mounted patient biopsies |
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom change
Time Frame: 14 days
|
Symptom change using the following questionnaires systems. IBS severity scoring system for symptom change (significant if > 50 points) before and after treatment. Gastrointestinal Symptom Rating Scale-IBS and Visceral sensitivity index. Data analyzed by cluster or as a total score for all items with statistically significant change. Hospital Anxiety and Depression Scale. Cut-off values are indicated as ≥8 for subclinical (suspicious) anxiety or depression and ≥11 as definite cases on both the HADS-D and HADS-A, respectively. Short Health Scale. Data analyzed by cluster or as a total score for all items with statistically significant change. |
14 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Susanna Walter, MD, University Hospital, Linköping, Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- referm-barrier
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on IBS - Irritable Bowel Syndrome
-
Guy BoeckxstaensFund for Scientific Research, Flanders, BelgiumRecruiting
-
Kyle Staller, MD, MPHArdelyxRecruitingIBS - Irritable Bowel Syndrome | IBSUnited States
-
University of California, Los AngelesRecruitingIBS - Irritable Bowel SyndromeUnited States
-
AstraZenecaCompletedIrritable Bowel Syndrome-IBSChina
-
Arizona State UniversityCompletedIBS - Irritable Bowel SyndromeUnited States
-
Xiyuan Hospital of China Academy of Chinese Medical...UnknownIBS (Irritable Bowel Syndrome)China
-
Seton Healthcare FamilyWithdrawnIrritable Bowel Syndrome (IBS)United States
-
Glycom, Inc.University of North CarolinaCompletedIrritable Bowel Syndrome (IBS)United States
-
GlaxoSmithKlineCompletedIrritable Bowel Syndrome (IBS)United States
-
The Royal Wolverhampton Hospitals NHS TrustRecruiting
Clinical Trials on ReFerm(R)
-
University of California, Los AngelesUniversity of Colorado, Denver; National Institute of Allergy and Infectious... and other collaboratorsCompletedRNA Virus Infections | Respiratory Tract Infections | Influenza, Human | Orthomyxoviridae Infections | Respiratory Tract Disease | Virus Disease | Physiological Effects of Drugs | VaccinesUnited States
-
Klinikum NürnbergUnknown
-
University of California, Los AngelesNational Institute of Allergy and Infectious Diseases (NIAID)CompletedRespiratory Tract Infections | Influenza | VaccinesUnited States
-
LifeScanCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedHealthy VolunteersFrance
-
Daping Hospital and the Research Institute of Surgery...Not yet recruiting
-
Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)Not yet recruiting
-
University of Colorado, DenverAgency for Healthcare Research and Quality (AHRQ)CompletedImmunization RatesUnited States
-
James A. Haley Veterans Administration HospitalCompleted