Study on the Effectiveness of E. coli DSM 17252 for Patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

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What is this study about?

This clinical trial is focused on studying a condition known as Irritable Bowel Syndrome, specifically the type that mainly causes diarrhea, referred to as IBS-D. The treatment being tested is called Symbioflor®2, which contains living bacteria known as Escherichia coli DSM 17252. The trial will compare the effects of this treatment to a placebo, which looks and feels the same as the treatment but does not contain the active bacteria.

The purpose of the study is to see how effective Symbioflor®2 is in reducing the frequency and severity of symptoms in patients with IBS-D. It will also assess the safety and how well patients tolerate the treatment. Participants in the study will take the treatment or placebo orally, meaning they will swallow it, over a period of 26 weeks. During this time, researchers will monitor changes in symptoms and any side effects experienced by the participants.

Throughout the study, participants will be asked to report on their symptoms, such as abdominal pain and stool consistency, using simple scales. This will help researchers determine if the treatment is making a significant difference compared to the placebo. The study aims to provide valuable information on whether Symbioflor®2 can be a helpful treatment option for those suffering from IBS-D.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objective, which is to evaluate the effectiveness, safety, and tolerability of the oral treatment with living bacteria of E. coli DSM 17252 (Symbioflor®2) in patients with diarrhoea-predominant irritable bowel syndrome (IBS-D).

The patient will be required to provide written informed consent before participating in the trial.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility, which includes a diagnosis of irritable bowel syndrome according to specific criteria and a colonoscopy with no clinically relevant findings.

Female patients of childbearing potential must have a negative pregnancy test at screening and baseline.

3 treatment phase

The patient will receive either the Symbioflor®2 oral drops or a placebo. The placebo is identical in appearance and composition to Symbioflor®2, except it does not contain the active ingredient.

The treatment will be administered orally as drops, and the patient will be instructed on the dosage and frequency of administration.

4 monitoring and evaluation

Throughout the trial, the patient will be monitored for changes in symptoms using the Bristol Stool Scale and an 11-point numeric rating scale for abdominal pain intensity.

The primary goal is to achieve at least a 50% reduction in the number of days with stool consistency of 6 or 7 and a decrease in the weekly average of worst abdominal pain.

5 completion of the trial

The trial is expected to last for 26 weeks, during which the patient will continue to receive the treatment and undergo regular assessments.

Upon completion, the patient’s response to the treatment will be evaluated based on the improvement in IBS symptoms and overall tolerability of the treatment.

Who Can Join the Study?

Must be a male or female outpatient aged 18 years or older.
Must have a diagnosis of irritable bowel syndrome (IBS) according to Rome IV criteria, which includes:
- Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months.
- Pain associated with two or more of the following:
  - Related to defecation (going to the bathroom).
  - Associated with a change in how often you have a bowel movement.
  - Associated with a change in the form (appearance) of your stool.
- Symptoms must have been present for the last 3 months.
- IBS symptoms must have started at least 6 months ago.
- Must have the IBS-D subtype, where abnormal stools are usually diarrhea.
Must have had a colonoscopy (a test to look inside the colon) with no important findings:
- For patients younger than 50 years, the colonoscopy must have been done.
- For patients 50 years or older, the colonoscopy must have been done within the last 5 years.
Female patients who can have children must be surgically sterilized or use a highly effective method of birth control, with a negative pregnancy test at the start of the study.
Must be willing to avoid significant changes in diet, fiber intake, fluid intake, or physical activity during the study.
Must be willing to avoid using other medications for IBS treatment, including probiotic medication.
Must be able to follow the treatment plan.
Must have enough knowledge of the German language to understand trial instructions and rating scales.
Must provide written informed consent before joining the study.
Must have an email account and internet access available.

Who Cannot Join the Study?

Patients who are not diagnosed with Irritable Bowel Syndrome (IBS) cannot participate. IBS is a condition that affects the digestive system, causing symptoms like stomach pain and changes in bowel habits.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, so if you are outside these groups, you may not be eligible.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care, such as those with certain disabilities or conditions, are not included.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Gemeinschaftspraxis Dres. Holger Kittner und Kerstin Hartig	Naunhof	Germany
Berufsausübungsgemeinschaft Dr. Jörg Schulze	Jerichow	Germany
MVZ im Altstadt-Carree Fulda GmbH	Fulda	Germany
Klinische Forschung Karlsruhe GmbH	Karlsruhe	Germany

Other Sites

Site Name	City	Country
SRH Wald-Klinikum Gera GmbH	Gera	Germany
Klinische Forschung Hannover-Mitte GmbH	Hanover	Germany
Klinische Forschung Berlin-Mitte GmbH	Berlin	Germany
Klinische Forschung Hamburg GmbH	Hamburg	Germany
Ambenet GmbH Das Ambulante Behandlungsnetz	Leipzig	Germany
Medizentrum Essen Borbeck	Essen	Germany
Hausarztzentrum Butendorf	Gladbeck	Germany
medicoKIT GmbH	Goch	Germany
Siteworks GmbH	Hanover	Germany
Velocity Clinical Research Luebeck GmbH	Luebeck	Germany
Velocity Clinical Research Germany GmbH	Hamburg	Germany
Klinische Forschung Berlin GbR	Berlin	Germany
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH	Bamberg	Germany
Praxis Dr. Krönung	Offenbach Am Main	Germany
Studienzentrum Dr. Andreas Schwittay	Boehlen	Germany
Klinische Forschung Schwerin GmbH	Schwerin	Germany
Praxis Dr. Joachim Weimer	Reinfeld	Germany
CGBS GbR	Frankfurt	Germany
Universitätsklinikum Brandenburg an der Havel Gastroenterologie, Diabetologie, Hepatologie	Brandenburg An Der Havel	Germany
Ktaivqnck Fnuonbirh Dusxlyl Guqq	Dresden	Germany
Ivgkksltbykeag Poggrmhoccqafaoqzv Wekbouqeya	Hamburg	Germany
Iohtmkhseob aw Mnmzu Dpe Mk Smzqpyqnixyvme Dik At Lrqqegt	Köthen	Germany
Mor Mgaifojpyvxm Nyeavmlv Smfqmugigaegfg	Nürnberg	Germany
Ajajugl &ecvu Revzfus Grga	Berlin	Germany
Zccm Gozb	Stuttgart	Germany
Sxyrukudlumhgl Fkw Rffiyjac	Leipzig	Germany
Kwwwhuyj Edyznhykxbghogkbegkbxugw Hwotoukykbbepcrip	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.10.2019

Trial locations

Symbioflor®2 is a treatment that contains living bacteria of E. coli DSM 17252. It is used in this trial to help patients with diarrhoea-predominant irritable bowel syndrome (IBS-D). The goal is to see if it can reduce the frequency and severity of IBS-D symptoms. The trial also aims to check how safe and tolerable this treatment is for patients.

Irritable Bowel Syndrome – This is a common disorder affecting the large intestine, characterized by symptoms such as cramping, abdominal pain, bloating, gas, and diarrhea or constipation, or both. The exact cause of irritable bowel syndrome is unknown, but it is believed to involve a combination of abnormal gastrointestinal tract movements, increased sensitivity to pain, and changes in the gut microbiota. Symptoms can vary in intensity and may be triggered by certain foods, stress, or hormonal changes. The condition is chronic, meaning it requires long-term management, and symptoms can fluctuate over time. It does not cause changes in bowel tissue or increase the risk of colorectal cancer.

Trial ID:

2024-512104-19-00

Protocol code:

SymSF2

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of E. coli DSM 17252 for Patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

What is this study about?

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