DiverticulitisNCT03742076
Effect of Gum Arabic on Gastrointestinal Transit and Permeability
A study testing High-dose prebiotic and Low-dose prebiotic in people with Diverticulitis, run by Mayo Clinic at 1 site in United States.
Trial summary
The study aims to determine the effect of gum arabic on gut bacteria and GI function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diverticulitis
- What is being tested?
- High-dose prebiotic and Low-dose prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2018to 1 Mar 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent diagnosis of diverticulitis (within 24 months) and at least 4 weeks post antibiotic use
- Age 18-80
Who cannot join
- Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
- Known diagnosis of inflammatory bowel disease (Crohn's or ulcerative colitis), microscopic colitis, celiac disease, or other inflammatory condition other than diverticulitis
- Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- Use of NSAIDs or aspirin within the week prior to Visit 2 and Visit 5 (permeability and transit testing visit since NSAIDs affect intestinal permeability)
- Use of osmotic laxatives one week prior to Visit 2 and for the duration of the study
- Use of oral corticosteroids within the previous 6 weeks and for the duration of the study
Show all 14Show fewer
- Ingestion of artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages
- Antibiotic use within 4 weeks of completion of the initial stool kit and/or Visit 2 testing appointment and for the remainder of the study (they can complete the stool kit and Visit 2 after a 4-week washout period)
- Bowel preparation for colonoscopy less than one week prior to the completion of the first stool kit and Visit 2 and during the remainder of the study
- Pregnancy or plan to become pregnant within the study timeframe
- Vulnerable adults
- Egg allergy or resistant to ingesting eggs
- Diagnosis of diabetes
- Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The study aims to determine the effect of gum arabic on gut bacteria and GI function.
Read the detailed description
To compare the effect of placebo, low-dose prebiotic, or high-dose prebiotic on gut microbiota composition and function, GI transit and permeability, and assess development of symptoms or a change in pre-existing symptoms present, in patients with recent history of clinically diagnosed diverticulitis which has been successfully treated.
- Conditions
- Diverticulitis
- Being tested
- High-dose prebiotic, Low-dose prebiotic, Placebo
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose prebioticDietary supplement
Also called Acacia, gum acacia, acacia gum, gum arabic, arabic gum
This is a spray-dried powder, yellowish-white in color, that is dissolvable.
Low-dose prebioticDietary supplement
Also called Acacia, gum acacia, acacia gum, gum arabic, arabic gum
This is a spray-dried powder, yellowish-white in color, that is dissolvable.
PlaceboDietary supplement
Also called Dextrin fiber powder
Powder fiber supplement, yellowish-white in color, that is dissolvable.
| Study group | Role | What they receive |
|---|---|---|
| High-dose prebiotic | Active comparator | 10 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks Receives: Dietary Supplement: High-dose prebiotic |
| Low-dose prebiotic | Active comparator | 5 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks Receives: Dietary Supplement: Low-dose prebiotic |
| Placebo | Placebo comparator | 2 gm powdered fiber daily for at least 6 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic Transit time
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. Units: units on a scale
Measured: Change is being assessed between baseline and 6 weeks
Secondary outcomes (1)
Intestinal Permeability
To determine intestinal permeability, urine will be collected for 24 hours after drinking a sugar solution. The 0- to 2-hour urine most closely reflects small intestinal permeability and the 8- to 24-hour urine reflects colonic permeability. HPLC-tandem mass spectrometry will be used for detection of the sugars.
Measured: Change is being assessed between baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start18 Dec 2018
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Purna C. Kashyap, MBBS, Mayo Clinic
- Investigators
- Purna C Kashyap, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742076
- Sponsor's protocol ID
- 18-001008
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2018
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gum Arabic on Gastrointestinal Transit and Permeability
- ClinicalTrials.gov ID
- NCT03742076
- Acronym / sponsor ID
- 18-001008
- Conditions
- Diverticulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 15 Nov 2018 (actual)
- 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.
The study aims to determine the effect of gum arabic on gut bacteria and GI function.
Detailed description
To compare the effect of placebo, low-dose prebiotic, or high-dose prebiotic on gut microbiota composition and function, GI transit and permeability, and assess development of symptoms or a change in pre-existing symptoms present, in patients with recent history of clinically diagnosed diverticulitis which has been successfully treated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose prebiotic | Active comparator | Dietary Supplement: High-dose prebiotic10 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks |
| Low-dose prebiotic | Active comparator | Dietary Supplement: Low-dose prebiotic5 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 gm powdered fiber daily for at least 6 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recent diagnosis of diverticulitis (within 24 months) and at least 4 weeks post antibiotic use
- Age 18-80
Key exclusion criteria (14 listed)
- Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
- Known diagnosis of inflammatory bowel disease (Crohn's or ulcerative colitis), microscopic colitis, celiac disease, or other inflammatory condition other than diverticulitis
- Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- Use of NSAIDs or aspirin within the week prior to Visit 2 and Visit 5 (permeability and transit testing visit since NSAIDs affect intestinal permeability)
- Use of osmotic laxatives one week prior to Visit 2 and for the duration of 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 |
|---|---|---|
| High-dose prebioticAlso: Acacia, gum acacia, acacia gum, gum arabic, arabic gumThis is a spray-dried powder, yellowish-white in color, that is dissolvable. | Dietary supplement | High-dose prebiotic |
| Low-dose prebioticAlso: Acacia, gum acacia, acacia gum, gum arabic, arabic gumThis is a spray-dried powder, yellowish-white in color, that is dissolvable. | Dietary supplement | Low-dose prebiotic |
| PlaceboAlso: Dextrin fiber powderPowder fiber supplement, yellowish-white in color, that is dissolvable. | Dietary supplement | Placebo |
Primary outcome
Colonic Transit time
Time frame: Change is being assessed between baseline and 6 weeks
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. Units: units on a scale
1 secondary outcome
Intestinal Permeability
Time frame: Change is being assessed between baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Purna C Kashyap, MBBS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose prebiotic and Low-dose prebiotic in people with Diverticulitis, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 14 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: finished, as of the sponsor's last update on 10 Jul 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonic Transit time (time frame: Change is being assessed between baseline and 6 weeks). 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 10 Jul 2023.