Clinical trial NCT02074579: A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome
Official title: A Phase 2, Single-center, Randomized, Double-Blinded, Placebo-Controlled Study on the Efficacy of Daikenchuto (TU 100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome in Females
Keywords: Irritable Bowel Syndrome
Rome III criteria
abdominal bloating
natural
herbal
Kampo
Adult ages 18 to 65
Female subjects
Lead sponsor: Tsumura USA
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
First posted: 2014-02-28
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effect of orally administered TU-100 (5 g three times daily \[TID\]) as compared to placebo on abdominal bloating rating in female IBS patients.


Eligibility criteria: Inclusion Criteria:

* Meet Rome III criteria for IBS (any subtype)
* Female aged 18 to 65 years, inclusive
* If of childbearing potential, prepared to use suitable forms of contraception throughout the study and for 30 days after the last dose i.e., hormonal contraceptives (such as oral contraceptives, Depo-Provera, NuvaRing, Essure), condoms used with a spermicide, an intrauterine device, or abstinence. Females are not considered to be of childbearing potential if they are naturally postmenopausal (no menses for at least 1 year and, if \< 55 years of age, have a documented follicle-stimulating hormone \[FSH\] level of ≥ 35 mIU/mL) or have documentation of surgical sterility
* Have a BMI between 18 and 30 kg/m2, inclusive
* Have a negative pregnancy urine screening at Visit 1, if of childbearing potential
* Able to provide written consent
* Able to take oral administration of the testing medications
* Have a self-reported average abdominal bloating rating (\>3 daily ratings over the preceding 7 days) equal or greater than 4 on a numerical scale of 0 to 20.

Exclusion Criteria:

* Have a structural or metabolic disease or condition that affects the GI system, excluding asymptomatic gallstones or uncomplicated gastroesophageal reflux disease, or any medical condition that may be a cause of constipation or diarrhea (e.g., hypothyroid status, poorly controlled diabetes, diabetic neuropathy or autonomic neuropathy)
* Be taking any medication that, in the opinion of the Principle Investigator (PI), has potential to alter GI transit. A full list of prohibited medications is provided in the protocol. Have history or presence of any chronic lung disease
* Have presence of hepatic dysfunction, jaundice, or abnormal serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values exceeding 2.5 x upper limit of normal
* Currently pregnant or lactating
* Have a positive urine drug test at screening (subjects who initially test positive will be allowed one retest)
* Be a known substance abuser or be considered to be an alcoholic not in remission
* Have participated in another clinical study in the past 30 days
* Use of supplemental ginger, ginseng, or Zanthoxylum fruit for 2 weeks prior to randomization and throughout the course of the study.
* Have a history of allergic reaction to ginseng, ginger or Zanthoxylum fruit
* Be clinically lactose-intolerant
* Have any other condition that, in the opinion of the PI, causes the subject to be unsuitable to participate
* Have taken antibiotics in the last 3 months
* Have had gastroenteritis ("stomach flu") in the last 3 months
* Have taken probiotics in the last 3 months (over-the-counter \[OTC\] products or supplements only; food products such as yogurts are permitted).

Primary outcomes:
measure: Abdominal bloating rating
timeFrame: 4 weeks
Secondary outcomes:
measure: AUC for abdominal bloating ratings using lactulose challenge
timeFrame: Baseline and 4 weeks
measure: Abdominal bloating ratings
timeFrame: 4 weeks
measure: Overall IBS Severity
timeFrame: 4 weeks
measure: GI symptom ratings
timeFrame: 4 week
measure: Quality of Life effect
timeFrame: 4 weeks
measure: Mood symptom ratings
timeFrame: 4 weeks
Other outcomes:
measure: Physical Examination
timeFrame: 4 weeks
measure: Vital Signs
timeFrame: 4 weeks
measure: Adverse Events and Concomitant Medications
timeFrame: 8 weeks
measure: Laboratory safety tests
timeFrame: 8 weeks
Locations:
city: Los Angeles
country: United States
facility: Oppenheimer Family Center for Neurobiology of Stress Division of Digestive Diseases David Geffen School of Medicine at UCLA
state: California
Study officials:
affiliation: Oppenheimer Family Center of Neurobiology of Stress, UCLA
name: Kirsten Tillisch, MD
role: PRINCIPAL_INVESTIGATOR
References: