Effect of a Probiotic on Diverticular Symptoms
Primary Purpose
Diverticular Disease
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Probiotic
Sponsored by
About this trial
This is an interventional treatment trial for Diverticular Disease focused on measuring diverticular disease, diverticulitis, diverticulosis
Eligibility Criteria
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
Sites / Locations
- King's College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
Probiotic arm Liquid broth 1 mL/kg every morning for 90 days
Placebo arm Liquid broth 1 mL/kg each morning for 90 days
Outcomes
Primary Outcome Measures
Change in symptoms assessment score
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.
Secondary Outcome Measures
Change in faecal microbiota
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
Full Information
NCT ID
NCT02115867
First Posted
March 20, 2014
Last Updated
June 8, 2016
Sponsor
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02115867
Brief Title
Effect of a Probiotic on Diverticular Symptoms
Official Title
Assessment of the Probiotic Symprove as a Dietary Supplement in Patients With Symptomatic Diverticular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticular Disease
Keywords
diverticular disease, diverticulitis, diverticulosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Probiotic arm Liquid broth
1 mL/kg every morning for 90 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm Liquid broth
1 mL/kg each morning for 90 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Symprove probiotic
Intervention Description
Symprove probiotic
Primary Outcome Measure Information:
Title
Change in symptoms assessment score
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Change in faecal microbiota
Description
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
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingvar Bjarnason, MD, MSc
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Savvas Papagrigoriadis, MD, MSc
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE 9RS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of a Probiotic on Diverticular Symptoms
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