A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome

Phase 2

Completed

Conditions: Irritable Bowel Syndrome in Females

Interventions: Drug: TU-100
Drug: Placebo

Registration Number: NCT02074579

Lead Sponsor: Tsumura USA

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 101

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TU-100	TU-100	15g TU-100 (oral, daily) for 4 consecutive weeks (administered as 5g three times daily)
Matching placebo	Placebo	Matching placebo given 5g three times daily orally for 4 consecutive weeks

Primary Outcome Measures

Name	Time	Method
Abdominal bloating rating	4 weeks	Change in abdominal bloating rating, through comparison of the change in average ratings from the 7 days prior to baseline (Visit 2) to the last 7 days of the 4 week treatment period (Visit 4), between TU-100 15 g and placebo.

Secondary Outcome Measures

Name	Time	Method
Overall IBS Severity	4 weeks	Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) total score from baseline to Visits 3, 4, and 5
Abdominal bloating ratings	4 weeks	Change in the average of abdominal bloating ratings from the 7 days prior to baseline to the 7 days prior to Visit 3 (2 weeks) and to Visit 5 (8 weeks)
AUC for abdominal bloating ratings using lactulose challenge	Baseline and 4 weeks	Change in area under the curve (AUC) for abdominal bloating ratings obtained during the lactulose challenge at Visit 2 (baseline) and at Visit 4 (4 weeks). The data are collected at -0.5, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8 hours after taking test meal (lactulose).
Quality of Life effect	4 weeks	Change in IBS-QOL score from baseline to Visits 3, 4, and 5
Mood symptom ratings	4 weeks	Change in the average of mood symptom ratings from the 7 days prior to baseline to the 7 days prior to Visit 3 and to Visit 5
GI symptom ratings	4 week	Change in the average of GI symptom ratings from the 7 days prior to baseline to the 7 days prior to Visit 3 and to Visit 5

Trial Locations

Locations (1): Oppenheimer Family Center for Neurobiology of Stress Division of Digestive Diseases David Geffen School of Medicine at UCLA
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Los Angeles, California, United States