This is an observational study in which data from people with functional gastrointestinal disorders who decide on their own or by recommendation of their doctors or pharmacists to take Iberogast Advance are collected and studied. In observational studies, only observations are made without specified advice or interventions.
Functional stomach and bowel (or gastrointestinal) disorders are conditions in which the functionality of the gut, mainly the gut muscles or the gut/brain axis, is disturbed. Functional stomach and bowel disorders cause symptoms like heartburn, cramps and pain of the upper and middle part of the belly, also known as functional dyspepsia (FD) and irritable bowel syndrome (IBS). IBS affects predominantly the lower digestive system and causes symptoms like pain of the belly, cramps, bloating, diarrhea, and constipation.
Iberogast Advance is already available in German pharmacies without prescription for patients with gastrointestinal disorders such as FD and IBS. It contains herb extracts that work against inflammation, are calming, and protect the mucosa (innermost layer of the gastrointestinal tract). Earlier controlled studies with Iberogast Advance have shown how well it works and how it affects the body. Since Iberogast Advance is only available since October 2020, there is no information on its use in the real-world setting yet.
Therefore, the study researchers want to collect data on the use of Iberogast Advance in the real-world setting.
To do this, people with long-term and repeated functional gastrointestinal symptoms who purchase Iberogast Advance from participating pharmacies across Germany will be asked to fill out a questionnaire optionally covering 6 weeks of treatment. The participants will take Iberogast Advance as recommended in the product information.
The main purpose of this study is to see how well Iberogast Advance works and is perceived in the real-world setting. Participants will record how they experience a change of their gastrointestinal symptoms (assessed single-symptom-based) from start and during 6 weeks of treatment. Researchers will then compare the differences and analyze treatment effects.
The researchers will additionally collect information on usage behavior, characteristics of the patients, their symptoms, tolerability and their satisfaction with Iberogast Advance.
There will be no required tests or visits with a study doctor in this study. The researchers will collect the results of the patient questionnaires from Jun 2022 to January 2023.

Start Date04 Jun 2022

Sponsor / Collaborator

Bayer AG

NCT04656730

/ CompletedPhase 4IIT

Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas

Study to asess the effects of Iberogast® (STW5) and Iberogast® N (STW5-II) in intestinal gas transit and abdominal symptoms of patients suffering from irritable bowel syndrome or functional dyspepsia.

Start Date03 Sep 2020

Sponsor / Collaborator

Bayer Hispania SL

NCT04993989

/ CompletedNot Applicable

Pharmacy-based Study on the Effectiveness, Tolerability, Usage Behavior and User Satisfaction of Iberogast® in Functional and Motility-related Gastrointestinal Diseases, Preferably Irritable Bowel Syndrome.

Researchers want to learn more about the day-to-day use of Iberogast in people who have functional and motility-related gastrointestinal (stomach and bowel) diseases.
Functional and motility-related stomach and bowel diseases are conditions in which the functionality of the gut, mainly the gut muscles or the gut/brain axis is disturbed. Functional and motility related stomach and bowel diseases cause symptoms like heartburn, cramps and u pain of the upper and middle part of the belly, also known as functional dyspepsia (FD), and irritable bowel syndrome (IBS). IBS affects predominantly the lower digestive system and causes symptoms like pain of the belly, cramps, bloating, diarrhea, and constipation.
In this study, the researchers want to learn more about Iberogast, a plant-based treatment. Iberogast is available to treat stomach and bowel diseases such as FD and IBS.
Earlier studies with Iberogast have shown how well it works and how it affects the body. But, little is known about the day-to-day use of Iberogast and how satisfied patients are who take it. So in this study, the researchers want to learn more about Iberogast including:
* how well it works in day-to-day use
* how it affects the body, also referred to as tolerability
* how it is used day-to-day
* how safe it is
* how satisfied patients are who take it
To answer these questions, the researchers will collect information from pharmacies in Germany. Patients who get Iberogast from these pharmacies to help treat their gastrointestinal disease will complete a questionnaire before, during and after taking Iberogast. The researchers will use the results from the questionnaires to learn more about:
* the disease details of the patients who are taking Iberogast
* the patients' symptoms while taking Iberogast
* if the patients' symptoms change after taking Iberogast
* how satisfied patients are with Iberogast
* if the patients had adverse events
An adverse event is any medical problem that a participant has during a study.
This study will include patients in Germany who:
* have functional stomach and bowel symptoms or disorders like FD or IBS
* take Iberogast to treat symptoms of their stomach and bowel disease
* are able to complete the questionnaire
There will be no required tests or visits with a study doctor in this study. No treatments will be given as part of this study. The researchers will review information collected from patients who have decided for their own or by recommendation of their doctors or pharmacist to take Iberogast. The researchers will collect the results from the patient questionnaires from November 2017 to March 2018.

Start Date16 Nov 2017

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Iberogast

100 Translational Medicine associated with Iberogast

100 Patents (Medical) associated with Iberogast

Literatures (Medical) associated with Iberogast

01 Sep 2025·DIGESTIVE AND LIVER DISEASE

Mechanisms of action and clinical effectiveness of herbal treatments for disorders of gut-brain interaction

Review

Author: Holtmann, Gerald ; Efferth, Thomas ; Shah, Ayesha ; Kim, YongSung ; Moniruzzaman, Md ; Morrison, Mark ; Koloski, Natasha ; Chen, Minhu ; Gwee, Kok Ann ; Ayaki, Kana

Disorders of gut-brain interaction (DGBI), such as functional dyspepsia (FD) and irritable bowel syndrome (IBS), affect about one-third of the global population. Many patients turn to traditional and herbal medicines for relief, given the lack of effective therapies. This review assesses the clinical and preclinical evidence for herbal treatments used for patients with DGBI. Placebo-controlled trials show that specific herbal preparations, including peppermint oil, ginger, and commercial formulations like STW-5, ZZKZ and Rikkunshito significantly improve gastrointestinal symptoms. Their effectiveness likely arises from various mechanisms, such as alterations in gastrointestinal motility, desensitization of visceral sensory function, and suppression of low-grade mucosal or systemic inflammation. Recent studies of the effects of herbal extracts on the gastrointestinal microbiome also implicate microbial involvement in their effectiveness. Most herbal preparations contain multiple bioactive compounds to address various disease mechanisms, and there remains a significant gap in dose-response studies for optimizing therapeutic outcomes.

01 Jan 2025·REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS

Review

Author: Alcalá-González, Luis Gerardo ; Mendive, Juan Manuel ; Serrano Falcón, Blanca ; Serra, Jordi ; Santander Vaquero, Cecilio

Functional dyspepsia (FD) is a gut-brain axis disorder characterized by postprandial fullness, early satiety, bloating and/or epigastric pain, which are presumed to originate in the gastroduodenal tract. While the international recommendations in the Rome IV consensus require endoscopy to rule out an organic condition before establishing a diagnosis of FD, international guidelines recommend that, in the absence of risk factors, patient management be initiated at the primary care level by establishing Helicobacter pylori infection status, with eradication when positive, followed by empiric therapy with proton pump inhibitors and/or prokinetics, and that endoscopy be reserved for patients refractory to said measures. Second-line therapy includes neuromodulating agents, among which tricyclic antidepressants and atypical antipsychotics such as levosulpiride stand out. The latter has a predominant prokinetic effect, hence it is also used as first-line therapy for patients where early satiety and postprandial fullness predominate. Other therapy alternatives include phytotherapy using STW5 or peppermint/caraway oil, which have shown their superiority over placebo in controlled studies. Concurrently, dietary and lifestyle counseling, as well as psychological interventions such as cognitive-behavioral therapy, when available, may represent a therapeutic alternative worth considering for some patients.

01 Oct 2024·Neurogastroenterology and motility

Effect of Iberogast (STW5) on tolerance to colonic gas in patients with irritable bowel syndrome: A randomized, double‐blind, placebo control clinical trial

Article

Author: Benslaiman, Bouchra ; Serra, Jordi ; Aguilar, Ariadna

Abstract:

Background:

STW5 is an herbal medicinal product that, in previous studies, reduced abdominal pain in irritable bowel syndrome (IBS). The effect of STW5 on gas‐related abdominal symptoms is unknown.

Aim:

To determine the effects of STW5, compared to placebo, on the responses to colonic gas in IBS.

Methods:

Using a cross‐over design, two gas challenge tests were performed in 10 patients with IBS and bloating after 2‐weeks treatment with (a) STW5 and (b) placebo. The challenge test consisted in continuous infusion of gas into the colon (24 mL/min for 60 min), followed by a 30‐min free evacuation period. Gas evacuation, symptom perception, and abdominal distension were continuously registered.

Results:

Colonic gas filling was associated to a significant rise in abdominal symptom perception, that was significantly greater when patients were on‐placebo (score increment 4.0 ± 0.3) compared with on‐STW5 (score increment 3.2 ± 0.4; p = 0.035). Gas filling was associated to a progressive abdominal distension that was similar with both treatments. Opening of the rectal cannula produced a massive gas evacuation, similar after both treatments, associated to a return of abdominal perception and distension to basal levels when patients were on‐STW5 (score increment −0.1 ± 0.4; distension 0.3 ± 0.2 cm; p = 0.399, and p = 0.112 vs. basal), whereas both remained increased on‐placebo (score increment 0.5 ± 0.3; distension 0.8 ± 0.3 cm; p = 0.048, and p = 0.016 vs. infusion start).

Conclusions:

STW5 improves colonic gas tolerance in IBS patients with bloating without a significant effect on gas retention and evacuation. This medicinal product can be beneficious for treatment of gas‐related abdominal symptoms in patients with bloating. EudraCT: 2019‐003976‐38.

100 Deals associated with Iberogast

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Irritable Bowel Syndrome	Phase 3	Germany	Bayer AG	11 Oct 2013
Intestinal Obstruction	Phase 2	France	Nantes University Hospital	01 Apr 2016
Parkinson Disease	Phase 2	France	Nantes University Hospital	01 Apr 2016
Dyspepsia	Phase 2	Germany	Bayer AG	18 Jun 2009
Gastroesophageal Reflux	Phase 2	Germany	Bayer AG	18 Jun 2009
Heartburn	Phase 2	Germany	Bayer AG	18 Jun 2009

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EUCTR2019-003976-38-ES (EFFECT OF IBEROGAST (STW5), UEGW2022)	Phase 4	Irritable Bowel Syndrome	10	STW5 20 drops t.i.d.	ptqzsgbpbk(gysbribuoi) = jaqxozpihi hgzlpuljsi (lnvzbhnbww, 0.3)	Positive	09 Oct 2022
				Placebo	ptqzsgbpbk(gysbribuoi) = npxtjpgzvt hgzlpuljsi (lnvzbhnbww, 0.4)

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