Effect of a Probiotic on Diverticular Symptoms

NCT02115867 | Completed Phase 3

• 1 other identifier: 12/LO/1695
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Diverticular Disease

Keywords

diverticular disease; diverticulitis; diverticulosis

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (1)

• Change in faecal microbiota

  90 days

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Probiotic arm Liquid broth 1 mL/kg every morning for 90 days

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo arm Liquid broth 1 mL/kg each morning for 90 days

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Symprove probiotic

Also known as: Symprove probiotic

Placebo; Probiotic

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, SE 9RS, United Kingdom

Location

MeSH Terms

Conditions

Diverticular Diseases; Diverticulitis; Diverticulum

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ingvar Bjarnason, MD, MSc

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

• Savvas Papagrigoriadis, MD, MSc

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 9, 2016

Record last verified: 2014-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)