- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02115867
Effect of a Probiotic on Diverticular Symptoms
Assessment of the Probiotic Symprove as a Dietary Supplement in Patients With Symptomatic Diverticular Disease
Diverticulitis is an extremely common digestive disease particularly found in the large intestine in elderly patients and develops from diverticulosis. Diverticulosis is characterized by the formation of pouches (diverticula) that bulge to the outside of the colon, through areas of weakness in the colonic wall. Inflammation (diverticulitis) results if one of these diverticula becomes infected and / or obstructed. It is commonly accompanied by obvious or microscopic perforation, ranging in severity from a single, mild, acute attack of diverticulitis to more severe attacks characterized by abscess formation, occasionally resulting in chronic complications such as obstruction and fistula formation. After an episode of diverticulitis many patients develop changes in bowel openings, from diarrhoea and constipation, and many patients have abdominal pain and a symptom complex that resembles Irritable Bowel Syndrome (IBS).
According to available guidelines, treatment of symptomatic, but uncomplicated, diverticular disease aims to reduce the frequency and severity of diverticular related symptoms (abdominal pain, bloating, alterations in bowel habit) and to prevent complications. Different agents have been proposed, such as bulking agents, antispasmodics, and nonabsorbed topical antibiotics, 5amino acid preparations but these measures are unproven or controversial. It is thought that intestinal bacteria may play a significant role in the symptoms of post-diverticulitis.
The investigators have recently shown that a probiotic (Symprove) reduced the symptoms of IBS significantly in comparison with a placebo in a double-blind randomized trial and without side effects (paper in preparation). Because the symptoms in IBS and post-diverticulitis are so similar the investigators propose a double-blind placebo controlled trial of Symprove in patients with problematic diverticulitis. Patients will be recruited from a dedicated diverticulitis clinic using standard exclusion criteria. This is a 90 day symptom based trial using accepted outcome measures. If successful the results will have widespread implications for treatment of diverticular disease.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The patients for this study will be recruited from the diverticular disease clinic at King's College Hospital. The clinic is the first and the largest specialist diverticular clinic in the UK and attracts referrals directly from GP's, internal referrals from gastroenterology, in and outpatients and increasingly from Gastroenterology and Colorectal Surgery clinics in the South East of England. Eligible patients who meet fulfill the entry criteria will be invited to participate. They will receive a patient information sheet, which they take home with them for reading. They will then be seen again (usually within 2 weeks, or after any confirmatory tests have been completed) to discuss any questions that they may have and for a decision for inclusion into the trial.
Each will undergo a full blood count and conventional biochemistry and they will provide a stool sample for assessment of intestinal inflammation by a calprotectin estimation. They will also complete a baseline symptoms-based questionnaire. They will then be randomized to treatments A or B, both investigator and patient will be unaware of whether it is the active treatment (Symprove) or placebo. Each patient will complete the symptom-based questionnaire every 30 days while on on the 90 day treatment (Day 30, Day 60, and Day 90). The primary outcome measure will be a change in symptoms score from Day 0 to Day 90.
Also every 30 days while on treatment, stool tests will be repeated for faecal calprotectin. An additional sample will be frozen for eventual microbiota assessment. The secondary outcome measure will be change in the faecal microbiota between Day 0 and Day 90.
Patients will be seen in clinic 30 days after cessation of the trial (Day 120), at which time those patients on placebo will be offered a 90 day free treatment with the active ingredient if they so wish.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, SE 9RS
- King's College Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have a documented episode of diverticulitis as assesses clinically, on CT scans and a raised serological markers of inflammation
- Have problematic symptoms associated with established diverticular disease, post a diverticulitis episode
- Aged over 20 years
- Are on no treatment or have been on stabile medication for at least 6 weeks for diverticular disease
- Willing and able to provide a written informed consent.
Exclusion Criteria:
- Aged less than 20 years
- Severe disease (ongoing severe active diverticulitis) as defined by hemoglobin < 8.0 g/dl, white blood cell count, >20,000 cells/mm3, temperature >38.5°C, serum albumin < 25 g/dl
- Surgical diverticular complications such as rectovaginal or bladder fistula, abscess, etc.
- Severe respiratory, cardiovascular, neurological, psychiatric, rheumatological, other gastrointestinal, etc. diseases
- Undergone major intestinal resections
- Patients with malignancy
- On NSAIDs
- Pregnancy or actively seeking pregnancy
- History of intolerance or allergy to probiotics
- Current drug or alcohol dependence syndrome
- Patients unable to consent for themselves
- Patients with severe learning difficulties
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Probiotic
Probiotic arm Liquid broth 1 mL/kg every morning for 90 days |
Symprove probiotic
Other Names:
|
Placebo Comparator: Placebo
Placebo arm Liquid broth 1 mL/kg each morning for 90 days |
Symprove probiotic
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in symptoms assessment score
Time Frame: 90 days
|
The primary outcome in this study is the postulated improvement in symptom severity scores over the 90 day treatment period.
There is no generally approved or validated symptom severity scoring system for patients with diverticular disease.
In view of the fact that the symptoms (and possible the cause of symptoms) of post-diverticulitis is almost identical to that of IBS we propose to use this scoring system and we have added a separate additional pain score outcome as this is the principal symptoms that diverticulitis patients experience.
In addition to the symptoms based assessment, patients will complete an SF-8 questionnaire.
Both questionnaires will be completed prior to treatment initiation (Day 0) and again at the end of treatment (Day 90).
The change from baseline symptoms score to symptoms score at Day 90 will be the primary outcome measurement.
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in faecal microbiota
Time Frame: 90 days
|
Patients will submit a stool sample prior to treatment initiation and every 30 days after initiating treatment for assessment of faecal microbiota (Day 30, 60, and 90).
The secondary outcome measure for the study will be change in faecal microbiota between Day 0 and Day 90
|
90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ingvar Bjarnason, MD, MSc, King's College Hospital NHS Trust
- Principal Investigator: Savvas Papagrigoriadis, MD, MSc, King's College Hospital NHS Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12/LO/1695
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 Diverticular Disease
-
S.Eugenio HospitalUnknown
-
Jewish General HospitalCompletedUncomplicated Diverticular DiseaseCanada
-
Dongtan Sacred Heart HospitalUnknownSimple Diverticular DiseaseKorea, Republic of
-
Hospital Cristo ReCompletedDiverticular Disease of the ColonItaly
-
Justin MaykelRecruitingDiverticulitis | Uncomplicated Diverticular DiseaseUnited States
-
IRCCS Policlinico S. MatteoUnknownDiverticular Disease | Symptomatic Uncomplicated Diverticular DiseaseItaly
-
Catholic University of the Sacred HeartCompletedDiverticular DiseaseItaly
-
University Hospital, CaenAssociation Francaise de ChirurgieNot yet recruitingQuality of Life (QOL) After Elective Sigmoidectomy for Diverticular Diseases (DIVERTI) (DIVERTI-QDV)Diverticular Disease of Left Side of Colon
-
Universitaire Ziekenhuizen KU LeuvenUnknownSymptomatic Recurrent Diverticular Disease | Benign Adenomatous Sigmoidal Polyp, Requiring Surgery | Early Non-transmural SigmoidtumorBelgium
-
King's College Hospital NHS TrustCompleted
Clinical Trials on Probiotic
-
Fudan UniversityInner Mongolia Yili Industrial Group Co., LtdCompletedObesity | AdiposityChina
-
Universiti Kebangsaan Malaysia Medical CentreUnknownHypertension | Obesity | Type 2 Diabetes Mellitus | HyperlipidemiaMalaysia
-
Maastricht University Medical CenterCompleted
-
BiocodexCompletedAcute GastroenteritisArgentina
-
Fundació Sant Joan de DéuCompleted
-
University of LeedsUnknown
-
Centro Pediatrico Albina de PatinoCompletedAcute Gastroenteritis | Acute DiarrheaBolivia
-
Deivis de Oliveira guimaraesCompletedParkinson Disease | Alzheimer DiseaseBrazil
-
Lindenwood UniversityCompletedImmune and Recovery Modulating Impact of Probiotic Supplementation After Intense Resistance ExerciseMuscle Damage | Muscular Fatigue | Immune Markers | Complete Blood Count (CBC) With Platelet Differentials | Muscular Force Production | Countermovement Jump | Muscular SorenessUnited States
-
Shandong UniversityUnknownGastrointestinal Neoplasms | Colorectal Cancer | Malnutrition | Effects of Chemotherapy | Tumor ImmunityChina