BridgeMD
New treatment option for Disease Related Malnutrition
Official title Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement
ClinicalTrials.gov ID: NCT07417514
What this study is testing
- What it's testing
- To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition, taken either orally or via a feeding tube
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (≥18 years) who are able to communicate clearly.
- Diagnosis of renal disease or confirmed requirement for protein supplementation by a suitably qualified health care professional (e.g. dietitian)
- Participants with or at risk of malnutrition as determined by the SGA nutritional screening tool, MUST and/or by professional clinical judgement.
- Participants expected to require an ONS for at least 28 days from baseline, to take flavour variants orally and neutral via feeding tube.
- Informed consent obtained.
You likely can't join if
- Participation in any other studies involving investigational or marketed products concomitantly or within seven days prior to entry into the study
- Patients with medical or dietary contraindication to any ingredients (see appendix 2 of protocol for full list.)
- No feeding tube for any patient taking the neutral variant.
- Patients with significant hepatic impairment.
- Patients with dysphagia requiring IDDSI level 1 (or higher) fluids.
- Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
See the full eligibility criteria
- Adult patients (≥18 years) who are able to communicate clearly.
- Diagnosis of renal disease or confirmed requirement for protein supplementation by a suitably qualified health care professional (e.g. dietitian)
- Participants with or at risk of malnutrition as determined by the SGA nutritional screening tool, MUST and/or by professional clinical judgement.
- Participants expected to require an ONS for at least 28 days from baseline, to take flavour variants orally and neutral via feeding tube.
- Informed consent obtained.
- Participation in any other studies involving investigational or marketed products concomitantly or within seven days prior to entry into the study
- Patients with medical or dietary contraindication to any ingredients (see appendix 2 of protocol for full list.)
- No feeding tube for any patient taking the neutral variant.
- Patients with significant hepatic impairment.
- Patients with dysphagia requiring IDDSI level 1 (or higher) fluids.
- Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
- Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
- Any participant unable to give consent i.e., those with dementia.
- Participants under 18 years of age.
- Individuals who do not have sufficient proficiency with English language
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.