Irritable Bowel Syndrome Clinical Trial
— TRAMIROfficial title:
TRApianto di Microbiota Intestinale in Pazienti Affetti da Sindrome Dell'Intestino IRritabile Senza Stipsi: Studio Clinico Randomizzato Controllato in Singolo Centro
Verified date | March 2023 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Irritable bowel syndrome (IBS) is a complex multifactorial functional disorder, whose pathophysiology is largely associated to an impairment of the intestinal microbiota composition, namely dysbiosis. Thus, the modulation of the gut microbiota has been proposed as a possible therapeutic strategy for IBS patients alongside with current available drugs. Fecal microbiota transplantation (FMT) is a promising strategy to restore intestinal eubiosis. In this randomised double-blind placebo-controlled trial patients diagnosed with IBS without constipation are assigned with 1:1 ratio to receive FMT from healthy donor or autologous FMT (placebo group) to assess the effectiveness of FMT on IBS symptoms and quality of life, to evaluate the safety of FMT among IBS patients and to estimate any change in the gut microbiota composition of IBS patients after the FMT.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | December 23, 2024 |
Est. primary completion date | March 23, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Ability to express and give informed consent - Age = 18 years - Diagnosis of diarrhoea-predominant or unclassified IBS, according to the Rome IV criteria - Have performed a colonoscopy within the last 5 years that has ruled out intestinal diseases Exclusion Criteria: - Taking antibiotics or probiotics within the 8 weeks before the baseline visit - Patients with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis or eosinophilic gastroenteritis), malignant neoplasms of the gastroenteric tract, celiac disease, diverticular disease - Uncontrolled heart failure or severe heart disease with EF < 30% - Severe respiratory failure - Serious psychiatric conditions or psychological instability according to the clinician - Contraindication to fecal microbiota transplantation (high risk of complications related to colonoscopy) - Previous abdominal surgery on the gastroenteric tract (except cholecystectomy, appendectomy and other types of surgery not involving the digestive tract) - Patients with cutaneous enterostomy - Pregnancy or lactation - Concurrent enrollment in other interventional experimental protocols - Personality unstable or unable to adhere to protocol procedures - Any clinical condition which, in the opinion of the investigators, may contraindicate enrollment in the study |
Country | Name | City | State |
---|---|---|---|
Italy | Giovanni Cammarota | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Cammarota G, Ianiro G, Magalini S, Gasbarrini A, Gui D. Decrease in Surgery for Clostridium difficile Infection After Starting a Program to Transplant Fecal Microbiota. Ann Intern Med. 2015 Sep 15;163(6):487-8. doi: 10.7326/L15-5139. No abstract available. — View Citation
Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13. — View Citation
Cammarota G, Masucci L, Ianiro G, Bibbo S, Dinoi G, Costamagna G, Sanguinetti M, Gasbarrini A. Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther. 2015 May;41(9):835-43. doi: 10.1111/apt.13144. Epub 2015 Mar 1. — View Citation
Ianiro G, Masucci L, Quaranta G, Simonelli C, Lopetuso LR, Sanguinetti M, Gasbarrini A, Cammarota G. Randomised clinical trial: faecal microbiota transplantation by colonoscopy plus vancomycin for the treatment of severe refractory Clostridium difficile infection-single versus multiple infusions. Aliment Pharmacol Ther. 2018 Jul;48(2):152-159. doi: 10.1111/apt.14816. Epub 2018 May 30. — View Citation
Ianiro G, Valerio L, Masucci L, Pecere S, Bibbo S, Quaranta G, Posteraro B, Curro D, Sanguinetti M, Gasbarrini A, Cammarota G. Predictors of failure after single faecal microbiota transplantation in patients with recurrent Clostridium difficile infection: results from a 3-year, single-centre cohort study. Clin Microbiol Infect. 2017 May;23(5):337.e1-337.e3. doi: 10.1016/j.cmi.2016.12.025. Epub 2017 Jan 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improving IBS symptoms assessed with the IBS severity scoring system (IBS-SSS) | To assess the effectiveness of healthy donor FMT in improving the symptoms of IBS without constipation compared to autologous microbiota transplantation using the IBS-SSS (< 175: mild IBS; 175-300: moderate IBS; > 300: severe IBS) | 365 days | |
Primary | Number and severity grade of adverse events after FMT | To assess the number and severity grade of adverse events occurred after FMT | 365 days | |
Secondary | Quality of life related to IBS evaluated with the IBS Quality of Life (IBS-QOL) questionnaire | To assess the effectiveness of healthy donor gut microbiota transplantation in improving the quality of life of patients with IBS without constipation compared to autologous FMT using the IBS-QOL questionnaire (range: 34-170; lower scores indicate better IBS-QoL) | 365 days | |
Secondary | Engraftment of donor microbiota after FMT, evaluated through the 16s rRNA sequencing | Changes in the fecal microbiota of the recipients after FMT from healthy donor or autologous microbiota transplantation will be evaluated through the 16s rRNA sequencing and compared to the baseline condition | 365 days |
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 |
NCT03318614 -
Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster
|
Phase 2/Phase 3 | |
Completed |
NCT02980406 -
The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level
|
N/A |