Simple Diverticular DiseaseNCT01831323
Evaluation of the Metabolome in Diverticular Disease
An observational study of Simple Diverticular Disease, run by S.Eugenio Hospital at 1 site in Italy.
Trial summary
To evaluate the effect of the probiotic formulation VSL#3 on the metabolome and microbiota of diverticular disease, comparing it with the effects exerted by supplementation with fibers, by rifaximin and by mesalazine, and assessing the evolution over time after each specific treatment Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Simple Diverticular Disease
- What is being tested?
- VSL#3, Rifaximin and Mesalazine
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with first diagnosis of uncomplicated symptomatic diverticular disease
Who may be able to join
- Female patients over 18 years of age
- Patient with a diagnosis of uncomplicated symptomatic diverticular disease diagnosed for the first time
- Patient able to comply with the procedures of the Protocol
- Ability to sign written informed consent
Who cannot join
- Segmental colitis associated with diverticulosis
- Inflammatory Bowel Disease
- Active or recent peptic ulceration
- Chronic renal failure
- Known allergy to products in the study
- Use of lactulose-lactitol in the two weeks prior to enrollment and during the study
Show all 18Show fewer
- Previous surgery of the colon
- Diverticular disease-related complications (fistulas, abscesses, stenosis)
- Use of probiotics in the 4 weeks prior to enrolment
- Renal, hepatic, hematologic, cardiovascular, pulmonary, neurological, psychiatric, immunological, gastrointestinal or endocrine disease, if found to be clinically significant
- Active malignancy or history of any type of malignancy.
- Recent history or suspicion of abuse of alcohol or drugs
- Women who are pregnant, nursing or of childbearing age not using appropriate contraceptive methods
- Any severe pathology that may interfere with the treatment
- Inability to provide written informed consent
- Not sufficiently reliable or presence of conditions that can result in non-compliance / patient adherence to the Protocol
- Previous participation in another study
- Lack of compliance towards the products in the study
Trial locations and contacts
1 site in 1 country.
Gianmarco Giorgetti, MD contact
Italy1 site, 1 recruiting
- Recruiting
Sant'Eugenio Hospital
Rome, RM, 00144
Gianmarco Giorgetti, MD, gianmarcogiorgetti@gmail.com
Gianmarco Giorgetti, MD
About this study
Official title: Evaluation of the Metabolome in Diverticular Disease and Effects of Probiotic Mixture VSL#3 vs Fibers, Rifaximin and Mesalazine on the Metabolome in Diverticular Disease of the Colon
To evaluate the effect of the probiotic formulation VSL#3 on the metabolome and microbiota of diverticular disease, comparing it with the effects exerted by supplementation with fibers, by rifaximin and by mesalazine, and assessing the evolution over time after each specific treatment
Read the detailed description
The incidence of diverticular disease of the colon has increased over the last few years. Since it presents potentially severe complications (both in terms of morbidity and mortality), the most recent studies are focusing on the underlying mechanisms and therapeutic options.
Diverticular disease of the colon presents important etiopathogenetic events. The first is that the severity of microscopic inflammation is correlated to the disease activity. The second is the bacterial overgrowth which is observed in the colon, where the diverticula form "recesses" where bacteria can proliferate. The third is that the "metabolome" plays an important role in the pathogenesis of diseases of the gastrointestinal tract (and not only). An extensive combination of microbial species live permanently in the human gut and participate in the metabolic activities of the gastro-intestinal tract (such as the synthesis of certain vitamins, improvement of the immune system, and balance of the resident bacterial species). There is little published clinical evidence suggesting a direct link between microbiota and diverticular disease; however, an altered microbiota in the flora of patients with colon cancer, irritable bowel syndrome, and IBD has been described.
It is clear that human metabolism and inflammatory response are influenced by genetic information outside our genome. Insights into the influence of microorganisms on the pathogenesis in gastrointestinal function and diverticular disease are in their infancy and often rely on extrapolation from other disease states. Microbiological analysis of fecal microbiota can provide important information on the role that the microbial-mammalian axis might have on the pathogenesis of diverticular disease.
Alteration of the metabolome play an important role in some pathologies of the gastrointestinal tract, from Inflammatory Bowel Diseases (IBD) to Irritable Bowel Syndrome (IBS). Most likely, it plays the same role in diverticular disease. In fact, the current western diet is poor in fibers and can cause an alteration of the resident bacterial species, with a reduction of bifidobacteria and an increase of clostridia.
This alteration might be present in diverticular disease and the manipulation of the microbial flora might represent both a treatment option for diverticular disease and the prevention of its complications.
Recent studies showed that the treatment with probiotics can help reduce the activity index in patients with DDS and as well as reduce the recurrence of the disease.
A new method has now been validated to assess the microbiota: the analysis of the faecal and urinary metabolome by high resolution Nuclear Magnetic Resonance (NMR) spectroscopy. The microbioma is the combination of the DNA of the microorganisms that compose the intestinal microflora (microbiota). Metabolomics allow to assess the metabolic activity of the microbiota and its possible interactions with the host.
The metabolomic analyses of stools and urine offer a new approach to evaluate the metabolome of diverticular disease, and compare it in patients who take a probiotic, fibers, non-absorbable antibiotics or an anti-inflammatory drug.
- Conditions
- Simple Diverticular Disease
- Being tested
- VSL#3, Rifaximin, Mesalazine, Psyllium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Dietary supplement
Also called Probiotic food supplement
VSL#3
RifaximinDrug
Also called Unabsorbable antibiotic
Rifaximin
MesalazineDrug
Also called anti-inflammatory drug
Mesalazine
PsylliumDietary supplement
Also called Fibers
psyllium
| Study group | Role | What they receive |
|---|---|---|
| mesalazine | 10 female patients with first diagnosis of SUDD will take mesalazine 1,6g per day for 14 days (1 tablet 800mg twice daily) Receives: Drug: Mesalazine | |
| VSL#3 | 10 female patients with first diagnosis of SUDD will take VSL#3 2 sachets a day for 14 days (1 sachet twice a day, for a total of 900 billion bacteria per day) Receives: Dietary Supplement: VSL#3 | |
| Rifaximin | 10 female patients with first diagnosis of SUDD will take 800mg/day of rifaximin (2 tablets of 200mg twice a day) Receives: Drug: Rifaximin | |
| fiber | 10 female patients with first diagnosis of SUDD will take fibers for 14 days (psyllium 10grams per day) Receives: Dietary Supplement: Psyllium |
What is being measured
The primary outcome is the main question the study is designed to answer.
identify the metabolome of symptomatic uncomplicated Diverticular Disease (SUDD)
As no studies have ever been conducted or published on this aspect, the main outcome of the study is to analyze and identify the metabolome of patients with SUDD before starting any therapy and after a 2 week therapy of a probiotic, fibers or antibiotics. The metabolomic analysis will allow a precise evaluation of the systemic and organ-specific processes based on low molecular weight components thus providing a profile of the metabolic system of these patients.
Measured: 12 months
verify changes in the intestinal microbiota following treatment in the different study groups.
Measured: 12 months
Secondary outcomes (4)
evaluate the symptomatology and metabolome
Evaluate the difference in symptomatology in the different groups, in particular stool frequency, abdominal pain, mucus or blood in faeces, intestinal gas, and assess possible link to the different metabolome and microbiota
Measured: 12 months
evaluate the different metabolomes and microbiota according to the treatment used
Evaluate if the variation in metabolome and microbiota induced by the different treatments modify the symptomatology of the patients and for how long.
Measured: 12 months
Evaluate the effects of supplementation with VSL#3 on the metabolome and microbiota of Diverticular Disease
Evaluate the effects of supplementation with VSL#3 on the metabolome and microbiota of Diverticular Disease, comparing it with the effects of supplementation with fibers, or treatment with rifaximin or with mesalazine.
Measured: 12 months
evaluate if difference in the symptomatology in the different groups are correlated with changes in the intestinal microbiota
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simple Diverticular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.Eugenio Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gian Marco Giorgetti, S.Eugenio Hospital
- Investigators
- Gianmarco Giorgetti, Principal investigator, Sant'Eugenio Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831323
- Sponsor's protocol ID
- TUR-SUDD 2012
- Status last verified
- Oct 2014
- First submitted
- 4 Dec 2012
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Metabolome in Diverticular Disease and Effects of Probiotic Mixture VSL#3 vs Fibers, Rifaximin and Mesalazine on the Metabolome in Diverticular Disease of the Colon
- ClinicalTrials.gov ID
- NCT01831323
- Acronym / sponsor ID
- TUR-SUDD 2012
- Conditions
- Simple Diverticular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- S.Eugenio HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of the probiotic formulation VSL#3 on the metabolome and microbiota of diverticular disease, comparing it with the effects exerted by supplementation with fibers, by rifaximin and by mesalazine, and assessing the evolution over time after each specific treatment
Detailed description
The incidence of diverticular disease of the colon has increased over the last few years. Since it presents potentially severe complications (both in terms of morbidity and mortality), the most recent studies are focusing on the underlying mechanisms and therapeutic options.
Diverticular disease of the colon presents important etiopathogenetic events. The first is that the severity of microscopic inflammation is correlated to the disease activity. The second is the bacterial overgrowth which is observed in the colon, where the diverticula form "recesses" where bacteria can proliferate. The third is that the "metabolome" plays an important role in the pathogenesis of diseases of the gastrointestinal tract (and not only). An extensive combination of microbial species live permanently in the human gut and participate in the metabolic activities of the gastro-intestinal tract (such as the synthesis of certain vitamins, improvement of the immune system, and balance of the resident bacterial species). There is little published clinical evidence suggesting a direct link between microbiota and diverticular disease; however, an altered microbiota in the flora of patients with colon cancer, irritable bowel syndrome, and IBD has been described.
It is clear that human metabolism and inflammatory response are influenced by genetic information outside our genome. Insights into the influence of microorganisms on the pathogenesis in gastrointestinal function and diverticular disease are in their infancy and often rely on extrapolation from other disease states. Microbiological analysis of fecal microbiota can provide important information on the role that the microbial-mammalian axis might have on the pathogenesis of diverticular disease.
Alteration of the metabolome play an important role in some pathologies of the gastrointestinal tract, from Inflammatory Bowel Diseases (IBD) to Irritable Bowel Syndrome (IBS). Most likely, it plays the same role in diverticular disease. In fact, the current western diet is poor in fibers and can cause an alteration of the resident bacterial species, with a reduction of bifidobacteria and an increase of clostridia.
This alteration might be present in diverticular disease and the manipulation of the microbial flora might represent both a treatment option for diverticular disease and the prevention of its complications.
Recent studies showed that the treatment with probiotics can help reduce the activity index in patients with DDS and as well as reduce the recurrence of the disease.
A new method has now been validated to assess the microbiota: the analysis of the faecal and urinary metabolome by high resolution Nuclear Magnetic Resonance (NMR) spectroscopy. The microbioma is the combination of the DNA of the microorganisms that compose the intestinal microflora (microbiota). Metabolomics allow to assess the metabolic activity of the microbiota and its possible interactions with the host.
The metabolomic analyses of stools and urine offer a new approach to evaluate the metabolome of diverticular disease, and compare it in patients who take a probiotic, fibers, non-absorbable antibiotics or an anti-inflammatory drug.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mesalazine | – | Drug: Mesalazine10 female patients with first diagnosis of SUDD will take mesalazine 1,6g per day for 14 days (1 tablet 800mg twice daily) |
| VSL#3 | – | Dietary Supplement: VSL#310 female patients with first diagnosis of SUDD will take VSL#3 2 sachets a day for 14 days (1 sachet twice a day, for a total of 900 billion bacteria per day) |
| Rifaximin | – | Drug: Rifaximin10 female patients with first diagnosis of SUDD will take 800mg/day of rifaximin (2 tablets of 200mg twice a day) |
| fiber | – | Dietary Supplement: Psyllium10 female patients with first diagnosis of SUDD will take fibers for 14 days (psyllium 10grams per day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with first diagnosis of uncomplicated symptomatic diverticular disease
Key inclusion criteria (4 listed)
- Female patients over 18 years of age
- Patient with a diagnosis of uncomplicated symptomatic diverticular disease diagnosed for the first time
- Patient able to comply with the procedures of the Protocol
- Ability to sign written informed consent
Key exclusion criteria (18 listed)
- Segmental colitis associated with diverticulosis
- Inflammatory Bowel Disease
- Active or recent peptic ulceration
- Chronic renal failure
- Known allergy to products in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSL#3Also: Probiotic food supplementVSL#3 | Dietary supplement | VSL#3 |
| RifaximinAlso: Unabsorbable antibioticRifaximin | Drug | Rifaximin |
| MesalazineAlso: anti-inflammatory drugMesalazine | Drug | mesalazine |
| PsylliumAlso: Fiberspsyllium | Dietary supplement | fiber |
Primary outcome
identify the metabolome of symptomatic uncomplicated Diverticular Disease (SUDD)
Time frame: 12 months
As no studies have ever been conducted or published on this aspect, the main outcome of the study is to analyze and identify the metabolome of patients with SUDD before starting any therapy and after a 2 week therapy of a probiotic, fibers or antibiotics. The metabolomic analysis will allow a precise evaluation of the systemic and organ-specific processes based on low molecular weight components thus providing a profile of the metabolic system of these patients.
verify changes in the intestinal microbiota following treatment in the different study groups.
Time frame: 12 months
4 secondary outcomes
evaluate the symptomatology and metabolome
Time frame: 12 months
evaluate the different metabolomes and microbiota according to the treatment used
Time frame: 12 months
Evaluate the effects of supplementation with VSL#3 on the metabolome and microbiota of Diverticular Disease
Time frame: 12 months
evaluate if difference in the symptomatology in the different groups are correlated with changes in the intestinal microbiota
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
Related trials for Simple Diverticular Disease
Active, not recruitingEarly Phase 1
FMT in Uncomplicated Diverticulitis
Diverticulitis, Uncomplicated Diverticular Disease
Active, not recruiting
Effect of Nutritional Counseling and Mediterranean Diet on Patients With Diverticular Disease
Diverticular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianmarco Giorgetti, MD contact
Gianmarco Giorgetti principal investigator
Sant'Eugenio Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Simple Diverticular Disease, run by S.Eugenio Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianmarco Giorgetti, MD (gianmarcogiorgetti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identify the metabolome of symptomatic uncomplicated Diverticular Disease (SUDD) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.