Irritable Bowel Syndrome Clinical Trial
Official title:
Effect of Herbal Extract Granules Combined With Probiotics on Irritable Bowel Syndrome With Diarrhea
The aims of this study are to investigate the effect of famous herbal formula extract and probiotics on irritable bowel syndrome with diarrhea, and to determine whether these two experimental items affect intestinal permeability and the composition of intestinal microbiota.
Irritable bowel syndrome (IBS), a common chronic gastrointestinal disorder characterized by
abdominal pain and alteration of bowel habits in the absence of structural abnormality, has
a prevalence of approximately 15% in western populations1,2. Patients with IBS can be
classified by their predominant bowel habits: diarrhea-predominant IBS (D-IBS),
constipation-predominant IBS, or IBS with alternating bowel movements3. Although
smooth-muscle relaxants, bulking agents, and anti-diarrheal agents are commonly used as
conventional IBS treatments, many IBS patients turn to alternative treatments because of the
lack of therapeutic advantages of these treatments4. Therefore, the development of a new
therapy is necessary for IBS patients.
Gwakhyangjeonggisan (GJS; Kkako-shoki-san in Kampo Medicine; Huoxiang-zhengqi-san in
Traditional Chinese Medicine), which was recorded originally in the famous ancient herbal
formula literature "Formularies of the Bureau of people's Welfare Pharmacies", consists of
13 common crude herbs. GJS contains the chemical ingredients naringin, hesperidin, thymol,
honokiol and magnolol5. GJS has been shown to protect intestinal barrier function6, contract
the colonic muscle7, and regulate infectious diarrhea8 in vivo. In traditional Korean
medicine, this herbal formula has long been used for relieving abdominal pain, diarrhea, and
vomiting as an over-the-counter or prescribed medicine9-11. However, there have been no
clinical trials to investigate the efficacy of GJS in IBS.
Probiotics are defined as viable microorganisms, which confer potential health benefits on
the host when taken in proper amounts12. They are easily available, do not require a
prescription, and are administered extensively for the relief of abdominal symptoms13.
According to a recent systematic review and meta-analysis study, probiotics caused a modest
improvement in the overall IBS symptoms14. The rationale for using probiotics for IBS is
based on the assumption that they modify the composition of the intestinal microflora15 and
regulate intestinal permeability by modulating the epithelial tight junctions16. Duolac7S
(DUO), a probiotic mixture, contains 7 bacterial species including Bifidobacterium,
Lactobacillus, and Streptococcus. Each of these bacterial species is reportedly beneficial
for IBS17. DUO has been approved by the Korean Food and Drug Administration for restoring
the ecological balance of intestinal microflora and improving intestinal symptoms18.
Although DUO has been widely used as an over-the-counter product for IBS-related symptoms,
no clinical trials have investigated the efficacy of DUO on IBS.
Recently, several herbal formulas and probiotics have been simultaneously administered to
IBS patients for relieving abdominal symptoms19. In addition to lack of clinical evidence
for the use of GJS or DUO, the efficacy of their combined treatment for IBS has not been
elucidated. Thus, there is a need to evaluate the safety and efficacy of administration of
GJS, DUO, or a combination therapy as a frequently used treatment for IBS. In the current
trial, we identified the safety and efficacy of GJS, DUO, or a combination therapy on D-IBS
by evaluating IBS symptoms and quality of life. To investigate their mechanisms in humans,
intestinal permeability and composition of intestinal microbiota were assessed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03720314 -
Microbiota Profiling in IBS
|
||
| Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
| Completed |
NCT05213910 -
Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
|
N/A | |
| Recruiting |
NCT05985018 -
Traditional Dietary Advice Vs. Mediterranean Diet in IBS
|
N/A | |
| Completed |
NCT04486469 -
Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study.
|
N/A | |
| Completed |
NCT06407609 -
Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS
|
N/A | |
| Completed |
NCT04656730 -
Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas
|
Phase 4 | |
| Completed |
NCT04145856 -
Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico
|
Phase 4 | |
| Recruiting |
NCT04138225 -
The Ecological Role of Yeasts in the Human Gut
|
||
| Active, not recruiting |
NCT03586622 -
One Year Home Monitoring and Treatment of IBS Patients
|
N/A | |
| Completed |
NCT05207618 -
Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant
|
N/A | |
| Not yet recruiting |
NCT06369753 -
Visible Abdominal Distension
|
N/A | |
| Not yet recruiting |
NCT05157867 -
In Vivo Effects of Amylase Trypsin Inhibitors
|
N/A | |
| Not yet recruiting |
NCT05100719 -
The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)
|
N/A | |
| Recruiting |
NCT05001997 -
Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome
|
N/A | |
| Recruiting |
NCT02953171 -
Probiotics in the Treatment of Irritable Bowel Syndrome
|
N/A | |
| Completed |
NCT02977975 -
Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
|
N/A | |
| Completed |
NCT03266068 -
Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
|
||
| Completed |
NCT03318614 -
Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster
|
Phase 2/Phase 3 | |
| Completed |
NCT02980406 -
The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level
|
N/A |