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Acropolis study

Evaluation of gastrointestinal tolerance of two enteral nutrition formulae

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON19872
Enrollment
30
Registered
2008-10-03
Start date
2008-10-06
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indication for tube nutrition

Interventions

Daily intake of study product. Total duration of intervention: 4 weeks
2 weeks first study product followed by 2 weeks second study product. Specification of intervention: The study product will replace the tube nutrition that is received by the subject prior to th

Sponsors

Danone Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Receiving enteral nutrition via a nasogastric tube or Percutaneous Endoscopic Gastrostomy (PEG) 3. Use of enteral nutrition as main source of nutrition 4. Written informed consent from either patient or legal representative for patients who cannot consent themselves

Exclusion criteria

Exclusion criteria: 1. Use of antibiotics in the past 2 weeks 2. Ulcerative colitis or Crohns disease 3. Presence of colostomy 4. Known intolerance or allergy to ingredients of study product 5. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements 6. Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Design outcomes

Primary

MeasureTime frame
Gastrointestinal tolerance measured by defecation pattern and self-reported GI symptoms.

Contacts

Public ContactM. Klebach

Danone Research P.O. Box 7005

marianne.klebach@danone.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)