Product image of Mutaflor (Escherichia Coli Strain Nissle 1917) supplied by GNH India

Mutaflor

Active Ingredient:
Escherichia Coli Strain Nissle 1917
Origin:
EU

Mutaflor (Escherichia Coli Strain Nissle 1917)

Escherichia coli Nissle 1917, the active ingredient in Mutaflor, is a probiotic presented as an oral formulation for oral administration. It belongs to the gastrointestinal microbiota modulator class and is used to support intestinal balance and to maintain remission in patients with ulcerative colitis.

GNH India supplies Mutaflor as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches to meet the needs of healthcare providers across multiple regions.

Manufacturer / TM Owner

Ardeypharm Gmbh

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Indications & Clinical Uses

Mutaflor, a probiotic targeting the gastrointestinal microbiota, is indicated for the following condition:

  • Ulcerative colitis (maintenance of remission): helps sustain a disease‑free state in patients who have achieved remission.

How It Works

  • Mutaflor delivers live Escherichia coli Nissle 1917 to the intestinal lumen, where it competes with pathogenic bacteria, reinforces the mucosal barrier, and modulates immune responses. The strain produces antimicrobial substances, stimulates secretory IgA, and influences cytokine profiles, collectively promoting a balanced gut microbiota and reducing intestinal inflammation.

Side Effects

Adverse reactions reported with Mutaflor are generally mild and reversible.

Common Side Effects

  • Abdominal discomfort: mild pain or cramping.
  • Flatulence: increased gas production.
  • Nausea: occasional feeling of queasiness.
  • Diarrhoea: loose stools.
  • Headache: transient mild headache.
  • Transient fever: low‑grade temperature rise.

Serious or Rare Side Effects

  • Bacteraemia: presence of bacteria in the bloodstream.
  • Sepsis: systemic infection requiring urgent care.
  • Severe allergic reaction: rash, swelling, or anaphylaxis.
  • Hypersensitivity: urticaria or angioedema.
  • Systemic infection in immunocompromised patients.
  • Persistent gastrointestinal infection.

Precautions & Warnings

Before prescribing Mutaflor, clinicians should consider the following precautions:

  • Immunocompromised patients: evaluate risk of systemic infection.
  • Recent antibiotic therapy: assess potential reduction in probiotic viability.
  • Underlying severe gastrointestinal disease: monitor for complications.
  • Pregnancy and lactation: safety data are limited; use only if clearly needed.
  • Pediatric use: limited data; prescribe with caution.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, and protect from moisture.

Avoid Interactions

Mutaflor may interact with other agents that affect gut flora or immune function.

Major Interactions (Avoid)

  • Broad‑spectrum antibiotics: may eradicate the probiotic strain and diminish efficacy.
  • Immunosuppressive biologics: increase risk of systemic infection.

Moderate Interactions (Monitor Closely)

  • Other probiotic products: potential competition for colonisation.
  • Antidiarrhoeal agents (e.g., loperamide): may alter transit time and affect bacterial survival.
  • Antifungal medications: possible indirect effects on gut microbiota balance.
  • Vaccines containing live attenuated organisms: consider timing to avoid interference.

Frequently Asked Questions

Mutaflor is a probiotic containing the live strain Escherichia coli Nissle 1917. It is prescribed primarily to help maintain remission in patients with ulcerative colitis by supporting a balanced intestinal microbiota and reducing inflammatory activity.

The Nissle 1917 strain colonises the gut lumen, competes with pathogenic microbes, strengthens the mucosal barrier, and modulates immune signalling. These actions collectively promote microbial equilibrium and dampen inflammatory pathways associated with ulcerative colitis.

The dosage regimen for Mutaflor is determined by the prescribing healthcare professional based on the patient’s condition, age, and clinical response. Patients should follow the specific instructions provided by their prescriber.

Safety data for Mutaflor in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any possible risk to the mother or infant, and the decision should be made in consultation with a qualified healthcare provider.

To request Mutaflor, submit an enquiry on the product page at gnhindia.com, indicating the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Unlike conventional anti‑inflammatory drugs, Mutaflor is a live probiotic that aims to restore microbial balance rather than directly suppress immune pathways. It is often used as an adjunct to standard therapy for maintenance of remission, whereas other agents such as mesalamine or biologics target inflammation more directly.

Mutaflor should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture, and avoid exposure to direct sunlight to maintain bacterial viability.

Mutaflor is taken orally, typically as a capsule or sachet containing the live bacterial strain. It should be swallowed with water according to the prescriber’s instructions, and may be taken with or without food depending on the specific guidance provided.

Serious risks, though rare, include systemic infection such as bacteraemia or sepsis, particularly in immunocompromised individuals. Severe allergic reactions, including anaphylaxis, have also been reported. Patients should seek immediate medical attention if they experience fever, chills, or signs of infection.

Mutaflor is contraindicated in patients with known hypersensitivity to Escherichia coli Nissle 1917 or any excipients in the formulation. Caution is advised for severely immunocompromised patients, those with uncontrolled systemic infections, and individuals for whom safety in pregnancy or lactation has not been established.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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