Probiotics in Functional Dyspepsia (ProPepsis)

Nordic Biotic

Status: Not yet enrolling

Conditions: Functional Dyspepsia

Treatments: Other: Maltodextrin (Placebo); Other: Lactobacillus

Study type: Interventional

Funder types: Industry

Identifiers

NCT07276009

MS-GIT-FD-A0004

Details and patient eligibility

About

The goal of this clinical trial is to learn whether a multi-strain probiotic can reduce digestive symptoms and improve quality of life in adults with functional dyspepsia. The main questions it aims to answer are:

• Does the probiotic reduce symptoms such as fullness after meals, bloating, stomach discomfort, and early satiation?
• Does the probiotic improve emotional well-being, including stress, anxiety, and mood? Researchers will compare the probiotic to a placebo (a look-alike capsule with no active ingredients) to see if the probiotic truly helps adults with functional dyspepsia.

Participants will:

• Take one capsule of the probiotic or placebo once daily before meals for 60 days
• Complete questionnaires about their digestive symptoms at the start, 1 month, and 2 months
• Complete surveys on stress, anxiety, depression, and quality of life at the start and 2 months
• Attend scheduled study visits for checkups and assessments

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-65 years

2. Diagnosis of Functional Dyspepsia based on Rome IV criteria, with symptoms present for at least 3 months, and symptom onset at least 6 months before diagnosis, including:

   • Postprandial fullness
   • Early satiation
   • Epigastric pain or burning
   • (with no evidence of structural disease explaining symptoms)

3. Moderate to severe symptom severity at baseline, as defined by a validated scale (e.g., NDI or global symptom score)

4. Normal upper GI endoscopy within the last 12 months (or at screening), excluding structural disease (e.g., peptic ulcer, malignancy)

5. Negative for H. pylori (either previously treated successfully or tested negative within study screening)

6. Ability and willingness to provide informed consent and comply with study procedures

7. Stable medication use, if any, for at least 4 weeks before screening (e.g., PPIs, antidepressants, laxatives)

Exclusion criteria

1. Evidence of structural GI disease (e.g., peptic ulcer, gastric cancer, celiac disease) on recent or screening endoscopy
2. History of gastrointestinal surgery affecting stomach or small intestine (except appendectomy or cholecystectomy)
3. Positive test for H. pylori during screening (or untreated known infection)
4. Current or recent use (within 4 weeks) of antibiotics, pre-, pro- or postbiotics, unless part of study protocol
5. Use of medications affecting GI motility (e.g., prokinetics, opioids, anticholinergics) within 2-4 weeks before enrollment
6. Overlap with other functional GI disorders (except IBS) if they are the dominant complaint, unless your protocol allows overlap
7. Clinically significant psychiatric illness (e.g., major depression, schizophrenia) that may interfere with symptom reporting or adherence
8. Severe systemic or metabolic disease (e.g., uncontrolled diabetes, renal or hepatic failure)
9. Pregnancy or lactation, or intention to become pregnant during the study period
10. Participation in another clinical trial within the past 3 months
11. Known allergy or intolerance to study product components

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

L. rhamnosus LR110, B. lactis BI040, B. breve BB010, L. paracasei LPC100, L. acidophilus LA120, L. casei LR130, L. plantarum LP140, S. thermophilus ST250, B. longum BL020, B. bifidum BF030 5 billion CFU one time daily for 60 days

Treatment:

Other: Lactobacillus

Placebo group

Placebo Comparator group

Description:

Product with excepients without probiotic bacteria one time daily for 60 days

Treatment:

Other: Maltodextrin (Placebo)