Novel Supplement-based Therapy for the Treatment of Small Intestinal Bacterial Overgrowth
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|ClinicalTrials.gov Identifier: NCT03420976|
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
This pilot study will determine the efficacy of a novel supplement protocol and low FODMAP diet for the treatment of small intestinal bacterial overgrowth (SIBO). The study will operate as a prospective, open label investigation, with an estimated sample size of 10 patients.
Patients diagnosed with SIBO by Dr. Nathan Morris, MD at Good Medicine Clinic (Oxford, Ohio) will be offered the opportunity to enroll in this study, if inclusion and exclusion criteria are met upon initial diagnosis. No control group will be assigned.
The diagnosis of SIBO will be determined via assessment of clinical symptoms and the results of a lactulose breath test. After administration of the supplement therapy and adherence to a low FODMAP diet (8 weeks), the lactulose breath test will be repeated and symptoms re-assessed by Dr. Morris. The post-treatment lactulose breath test and all supplements in the protocol will be provided free-of-charge to enrolled patients. In addition, enrolled patients will not be billed for the mid-treatment office visit. Patient and/or patient insurance will be responsible for all other expenses, including but not limited to the initial breath test, all other office visits and travel.
|Condition or disease||Intervention/treatment||Phase|
|Small Intestinal Bacterial Overgrowth||Dietary Supplement: Novel Supplement Based Therapy||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study: Investigating a Novel Supplement-based Therapy for the Treatment of Small Intestinal Bacterial Overgrowth|
|Actual Study Start Date :||December 7, 2017|
|Estimated Primary Completion Date :||January 30, 2019|
|Estimated Study Completion Date :||February 1, 2019|
Experimental: Novel Supplement-based Therapy
Low FODMAP diet + supplements outlined below:
Product Name: Liver-G.I. Detox Active Ingredients: Alpha lipoic acid, n-acetyl-l-cystine, turmeric root extract, milk thistle seed extract, broccoli sprout concentrate, artichoke leaf extract, taurine, glycine, l-glutamine, l-methionine, and chlorella.
Product Name: l-Glutamine Active Ingredients: l-glutamine
Product Name: MicroDefense Active Ingredients: berberine sulfate, olive leaf extract, sweet wormwood, clove bud powder, and grapefruit seed and fruit extract.
Product Name: A.C. Formulla II Active Ingredients: calcium and magnesium undecylenate, calcium and magnesium caprylate, bromelain, grapefruit seed and fruit extract, and berberine sulfate
Product Name: Probiotic-5 (Pure Encapsulations) Active Ingredients: Probiotic blend
Product Name: Digestive Enzymes Ultra with Betaine HCl Active Ingredients: Digestive enzyme blend and betaine HCl
Dietary Supplement: Novel Supplement Based Therapy
Supplements and Dosage:
Detox Support: Liver-G.I. Detox BID for 30 days GI Support: L-Glutamine Powder 2 scoops QD for 35 days Microbial Balance: MicroDefense 1 capsule QD for 49 days Microbial Balance: A.C. Formula II 2 capsules BID for 49 days Probiotic: Probiotic-5 1 capsule QD for 49 days Digestive Enzymes: Digestive Enzymes Ultra with Betaine HCl As needed up to 6 longer term
- Lactulose Breath Test [ Time Frame: 8 weeks ]Clinically and/or statistically significant reduction in hydrogen and methane levels following lactulose ingestion
- Symptom Survey [ Time Frame: 8 weeks ]Patient reported remission or improvement of SIBO-related symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420976
|Contact: Paul Larkinfirstname.lastname@example.org|
|Contact: Kara Badgley, BSemail@example.com|
|United States, Ohio|
|Oxford, Ohio, United States, 45056|
|Contact: Carman Clark 513-273-9944 firstname.lastname@example.org|
|Principal Investigator: Dr. Nathan Morris, MD|
|Principal Investigator:||Nathan Morris, MD||Good Medicine|