ClinicalTrials.gg
CompletedNCT03742076Updated Jul 10, 2023

Effect of Gum Arabic on Gastrointestinal Transit and Permeability

An interventional study of High-dose prebiotic and Low-dose prebiotic in Diverticulitis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-10.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diverticulitis

Browse trials for

03

In context

Diverticulitis

125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.

This study's enrollment of 27 is below the median of 120 across 63 interventional studies indexed under Diverticulitis.

Browse Diverticulitis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Recent diagnosis of diverticulitis (within 24 months) and at least 4 weeks post antibiotic use
  2. Age 18-80

Exclusion criteria

Exclusion Criteria:

  1. Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
  2. Known diagnosis of inflammatory bowel disease (Crohn's or ulcerative colitis), microscopic colitis, celiac disease, or other inflammatory condition other than diverticulitis
  3. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
  4. 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)
  5. Use of osmotic laxatives one week prior to Visit 2 and for the duration of the study
  6. Use of oral within the previous 6 weeks and for the duration of the study
  7. 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
  8. 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 )
  9. 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
  10. Pregnancy or plan to become pregnant within the study timeframe
  11. Vulnerable adults
  12. Egg allergy or resistant to ingesting eggs
  13. Diagnosis of diabetes
  14. 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
27 participants (actual)

Study arms

  • Active comparator
    High-dose prebiotic

    10 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks

    Dietary Supplement: High-dose prebiotic

  • Active comparator
    Low-dose prebiotic

    5 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks

    Dietary Supplement: Low-dose prebiotic

  • Placebo comparator
    Placebo

    2 gm powdered fiber daily for at least 6 weeks

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementHigh-dose prebiotic

    This is a spray-dried powder, yellowish-white in color, that is dissolvable.

    Also known as: Acacia, gum acacia, acacia gum, gum arabic, arabic gum

  • Dietary supplementLow-dose prebiotic

    This is a spray-dried powder, yellowish-white in color, that is dissolvable.

    Also known as: Acacia, gum acacia, acacia gum, gum arabic, arabic gum

  • Dietary supplementPlacebo

    Powder fiber supplement, yellowish-white in color, that is dissolvable.

    Also known as: Dextrin fiber powder

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: Change is being assessed between baseline and 6 weeks

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03742076
Lead sponsor
Mayo Clinic
Responsible party
Purna C. Kashyap, MBBS (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Nov 15, 2018
Start date
Dec 18, 2018
Primary completion
Mar 1, 2021
Completion
Mar 1, 2021
Last update
Jul 10, 2023

Study contacts

Purna C Kashyap, MBBS
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Prebiotics

Start the discussion