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

NCT04845217 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 21.0286
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Interstitial Cystitis

Keywords

interstitial cystitis; bladder pain syndrome; peppermint

Outcome Measures

Primary Outcomes (2)

• O'Leary/Sant questionnaire scores

  Participant responses to the O'Leary/Sant questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.

  8 weeks

• Pelvic Pain and Urgency/Frequency questionnaire scores

  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.

  8 weeks

Secondary Outcomes (3)

• Urine pH

  8 weeks

• Incidence of urinary tract infections (UTIs)

  8 weeks

• Additional IC/BPS Treatments received

  8 weeks

Study Arms (2)

Peppermint Oil

EXPERIMENTAL

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

Coconut Oil

PLACEBO COMPARATOR

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

Interventions

Peppermint oil DRUG

Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.

Also known as: Peptogest Peppermint Oil

Peppermint Oil

Coconut Oil DRUG

Enteric coated coconut oil taken by mouth three times daily for 8 weeks

Also known as: Coconut Oil Pure Extra Virgin

Coconut Oil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• Integrative Therapeutics, Inc.: collaborator

Study Sites (1)

Springs Medical Center

Louisville, Kentucky, 40205, United States

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

peppermint oil; Coconut Oil

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils

Study Officials

• Sean Francis, MD

  Department Chair

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna Warehime, DO

CONTACT

502-588-7660; pepperminttrial@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 14, 2021
• Study Start: September 15, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

US (1)