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Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04845217
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : September 30, 2021
Sponsor:
Collaborator:
Integrative Therapeutics, Inc.
Information provided by (Responsible Party):
Sean Francis, University of Louisville

Study Description
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Brief Summary:
The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Drug: Peppermint oil Drug: Coconut Oil Phase 1 Phase 2

Detailed Description:
After being informed about the study and potential risks, all participants will complete validated IC/BPS symptom questionnaires for baseline screening. Once participants meet eligibility requirements and give written informed consent they will be randomized in a 1:1 ratio to peppermint oil (200mg TID) or placebo (also TID). Participants will complete validated IC/BPS questionnaires and follow up surveys over 8 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized in a 1:1 ratio to the intervention or placebo arm. Allocation concealment will be in place to ensure the individual enrolling the subject into the study has no a priori knowledge of group assignment. Block randomization will occur with randomly mixed block sizes of 4, 6, and 8 using the randomization list generator at www.sealedenvelope.com. Randomization information will be kept confidential and only available to study personnel.
Masking: Single (Participant)
Masking Description:

The peppermint-oil and placebo treatments will be kept in a locked and secured area of the office, in a room not used for patient care. The bottles will be de-identified, with labels detailing the specific instructions for how to take the soft gels and the number in each bottle. Each group will be instructed to take one soft gel three times daily.

The peppermint oil and placebo medications will be distributed by the research team. The manufacturer label will be covered up/removed and a study label stating the use of a study medication will be used to maintain patient blinding.
Primary Purpose: Treatment
Official Title: Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain Syndrome
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Peppermint Oil
Participants in the intervention (peppermint oil) arm will receive soft gels of enteric-coated peppermint oil (0.2mL=200mg). The enteric coated peppermint oil soft gel utilized in this study is Peptogest Peppermint Oil from Schwabe North America (Nature's Way Brand).
 Drug: Peppermint oil
Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.
Other Name: Peptogest Peppermint Oil
Placebo Comparator: Coconut Oil
Participants in the placebo (coconut oil) arm will receive soft gels of enteric coated coconut oil. The enteric coated coconut oil soft gel utilized in this study is Coconut Oil from Schwabe North America (Nature's Way Brand).
 Drug: Coconut Oil
Enteric coated coconut oil taken by mouth three times daily for 8 weeks
Other Name: Coconut Oil Pure Extra Virgin


Outcome Measures
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Primary Outcome Measures :
  1. O'Leary/Sant questionnaire scores [ Time Frame: 8 weeks ]
    Participant responses to the O'Leary/Sant questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.

  2. Pelvic Pain and Urgency/Frequency questionnaire scores [ Time Frame: 8 weeks ]
    Participant responses to the Pelvic Pain and Urgency/Frequency questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.


Secondary Outcome Measures :
  1. Urine pH [ Time Frame: 8 weeks ]
    Changes in urine pH on urine dipstick from clinically indicated lab collections at the time of office visits during the study period

  2. Incidence of urinary tract infections (UTIs) [ Time Frame: 8 weeks ]
    Culture proven UTIs during the study period (>100,000 CFU of a single pathogen)

  3. Additional IC/BPS Treatments received [ Time Frame: 8 weeks ]
    Number and type of additional IC/BPS each participant undergoes


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women ages 18-65 years old
  • Diagnosed with IC/BPS for at least one month prior to study enrollment

Exclusion Criteria:

  • Culture proven urinary tract infection within 1 month of randomization
  • Gross hematuria
  • Currently pregnant or breastfeeding
  • Unable to speak and read English
  • History of allergic reaction to peppermint, coconut or enteric coating
  • History of malabsorption syndrome
  • History of gastroparesis
  • History of gastric bypass surgery
  • History of gastrointestinal, genitourinary or pelvic cancer in the last 5 years
  • History of insulin dependent diabetes
  • History of active urinary stone disease
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04845217


Contacts
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Contact: Jenna Warehime, DO 502-588-7660 jenna.warehime@louisville.edu

Locations
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United States, Kentucky
Springs Medical Center Recruiting
Louisville, Kentucky, United States, 40205
Contact: Sean Francis, MD         
Sponsors and Collaborators
University of Louisville
Integrative Therapeutics, Inc.
Investigators
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Principal Investigator: Sean Francis, MD Department Chair
More Information
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Responsible Party: Sean Francis, Professor, MD, University of Louisville
ClinicalTrials.gov Identifier: NCT04845217    
Other Study ID Numbers: 21.0286
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sean Francis, University of Louisville:
interstitial cystitis
bladder pain syndrome
peppermint
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Peppermint oil
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics