Tolerance to new fibre-enriched sip feed is equal to standard fibre-enriched sip feed.
ID
Bron
Verkorte titel
Aandoening
Malnutrition
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Tolerance, daily:<br>
1. Stool frequency;<br>
2. Incidence of liquid stools;<br>
3. Incidence and intensity gastrointestinal symptoms.
Achtergrond van het onderzoek
In this trial a new fibre-enriched sip feed will be compared with standard fibre-enriched sip feed on tolerance in subjects in need of nutritional support.
Doel van het onderzoek
Tolerance to new fibre-enriched sip feed is equal to standard fibre-enriched sip feed.
Onderzoeksopzet
Screening, Baseline, week 1, week 2, week 3, week 4 and Follow Up.
Onderzoeksproduct en/of interventie
Duration of intervention: 28 days;
Intervention group: new fibre-enriched sip feed;
Control group: standard fibre-enriched sip feed.
Publiek
Marjolein Miltenburg, van
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 800
Marjolein.vanmiltenburg@danone.com
Wetenschappelijk
Marjolein Miltenburg, van
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 800
Marjolein.vanmiltenburg@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Subjects (male/female) ≥ 50 years of age at the start of the Baseline period;
2. Subject is prescribed oral nutritional support of 300 kcal/day of sip feed (subject can be current or new user);
3. In case of new users: MUST score 1 (medium risk of malnutrition), or 2 or more (high risk of malnutrition);
4. Subject is expected to require oral nutritional support for at least 4 weeks;
5. Subject has given written informed consent;
6. Subject is able to comply with the protocol (e.g. answer questions).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Known inflammatory bowel diseases (e.g. Crohn’s disease);
2. Known lactose intolerance and not using lactase;
3. Known galactosemia;
4. Known cow’s milk allergy;
5. Known major hepatic dysfunction: symptomatic hepatic dysfunction or previous serum transaminase (ALAT, ASAT, or alkaline phosphatase) levels more than 5 times upper limit of normal;
6. Known major renal dysfunction: symptomatic renal dysfunction, previous serum creatinine level more than 1.8 times upper limit of normal, or requiring dialysis;
7. Subject with an ileostomy or colostomy;
8. Parenteral feeding;
9. Tube feeding;
10. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
11. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1996 |
NTR-old | NTR2113 |
Ander register | Danone Research – Centre for Specialised Nutrition : Sip.7.C/A |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |