Gastrointestinal ToleranceNCT07426406
Oral Nutritional Supplement in Adults With or at Risk of Malnutrition
A study testing Experimental Nutrition Product in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 3 sites in United Kingdom.
Trial summary
This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Tolerance
- What is being tested?
- Experimental Nutrition Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 22 Mar 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has voluntarily signed and dated an ICF approved by an EC and provided applicable privacy authorization prior to any participation in the study.
- Participant (male or female) is ≥ 18 years of age.
- Participant is considered by a dietitian or clinician as malnourished or at risk for malnutrition based on current use of ONS, recently identified as malnourished or at risk of malnutrition based on a validated malnutrition screening tool, or has had weight loss within the last two months as a result of a hospitalization or a chronic illness.
- Participant currently has normal GI function.
- Participant requires ONS as assessed by a dietitian or clinician and is willing to comply with the study protocol for at least 7 days.
- Non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the screening visit. A urine pregnancy test is required for all female participants unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to the screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
- If participant is of childbearing potential, the participant must agree to use effective forms of birth control methods for the duration of the study.
Who cannot join
- Participant has severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures.
- Participant has a history of uncontrolled diabetes as evidenced by HbA1c of > 9% within the last six months.
- Participant is currently taking or has taken antibiotics within 1 week prior to the feeding period (SDay 1 may be delayed until such time that the participant has completed a one-week washout period).
- Participant has undergone major GI surgery less than 3 months prior to enrollment in the study.
- Participant has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment.
- Participant has an allergy or intolerance to any ingredient in the study nutritional product.
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- Participant has an aversion to all of the flavours of product being assessed.
- Participant has an obstruction of the GI tract precluding ingestion or absorption of the study product, inflammatory bowel disease, gastric esophageal reflux disease, short bowel syndrome, or other major gastrointestinal disease-causing symptoms including (but not limited to) uncontrollable severe diarrhea, nausea, or vomiting. Exceptions include well-controlled reflux symptoms defined as no change in medication in the last 3 months.
- Participant is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility. Exceptions include multivitamins/mineral supplements, optical steroids, and inhaled steroids for asthma.
- Participation in another study that has not been approved as a concomitant study by Abbott.
- Participant has a clinical condition that is contraindicated with this product as determined by the clinician in accordance with standard of care.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Hull University Teaching Hospital
Anlaby, Hull, HU3 2PA
North Coast Medical
Newquay, Cornwall, TR7 1RU
Atlantic Medical Group
Penzance, Cornwall, TR18 3DX
About this study
Official title: A Study to Evaluate the Gastrointestinal Tolerance and Acceptability of a High Energy, High Protein, Oral Nutritional Supplement in Adults With or at Risk of Malnutrition
This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Experimental Nutrition Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Nutrition ProductOther
High energy, high protein oral nutritional supplement
| Study group | Role | What they receive |
|---|---|---|
| Experimental Nutrition Product | Experimental | 2 servings per day Receives: Other: Experimental Nutrition Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Tolerance
Bristol Stool Form Scale; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools
Measured: Study Day 1 - Study Day 7
Secondary outcomes (2)
Nutritional Supplement Palatability
Subject completed questionnaire; 4 questions scaled from 1 -Dislike Extremely to 9-Like Extremely; 2 questions scaled from Not at all Enough to Far Too
Measured: Study Day 1 - Study Day 7
Nutritional Supplement Compliance
Subject completed daily intake questionnaire including amount of serving consumed
Measured: Study Day 1 - Study Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start22 Mar 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Camprubi, PhD, Study chair, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426406
- Sponsor's protocol ID
- BM05
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Gastrointestinal Tolerance and Acceptability of a High Energy, High Protein, Oral Nutritional Supplement in Adults With or at Risk of Malnutrition
- ClinicalTrials.gov ID
- NCT07426406
- Acronym / sponsor ID
- BM05
- Conditions
- Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Nutrition Product | Experimental | Other: Experimental Nutrition Product2 servings per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant has voluntarily signed and dated an ICF approved by an EC and provided applicable privacy authorization prior to any participation in the study.
- Participant (male or female) is ≥ 18 years of age.
- Participant is considered by a dietitian or clinician as malnourished or at risk for malnutrition based on current use of ONS, recently identified as malnourished or at risk of malnutrition based on a validated malnutrition screening tool, or has had weight loss within the last two months as a result of a hospitalization or a chronic illness.
- Participant currently has normal GI function.
- Participant requires ONS as assessed by a dietitian or clinician and is willing to comply with the study protocol for at least 7 days.
Key exclusion criteria (11 listed)
- Participant has severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures.
- Participant has a history of uncontrolled diabetes as evidenced by HbA1c of > 9% within the last six months.
- Participant is currently taking or has taken antibiotics within 1 week prior to the feeding period (SDay 1 may be delayed until such time that the participant has completed a one-week washout period).
- Participant has undergone major GI surgery less than 3 months prior to enrollment in the study.
- Participant has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Nutrition ProductHigh energy, high protein oral nutritional supplement | Other | Experimental Nutrition Product |
Primary outcome
Gastrointestinal Tolerance
Time frame: Study Day 1 - Study Day 7
Bristol Stool Form Scale; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools
2 secondary outcomes
Nutritional Supplement Palatability
Time frame: Study Day 1 - Study Day 7
Nutritional Supplement Compliance
Time frame: Study Day 1 - Study Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Tolerance
Active, not recruiting
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
Insulin Resistance, Glucose Tolerance
Not yet recruitingEarly Phase 1
A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan Capsules
Lower Gastrointestinal Disorder, Tolerance
Not yet recruiting
Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
Gastrointestinal Tolerance, Gastrointestinal Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Camprubi, PhD study chair
Abbott
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Nutrition Product in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Tolerance (time frame: Study Day 1 - Study Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.