The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy

The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy - The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016939

Enrollment

Registered

2015-04-01

Start date

2015-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Dysphasia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In this study, we include the patients who are admitted to our hospital for periodic replacement of gastrostomy catheters under total enteral nutrition.

Exclusion criteria

Exclusion criteria: We exclude the patients who have any of the following items. 1) vomiting 2) diarrhea (frequency of mushy or watery stool is 3 times a day or more) 3) fever (body temperature is higher than 37.5 degree centigrade) 4) hypoxemia (oxygen saturation measured on room air is less than 92%)

Design outcomes

Primary

Measure	Time frame
Gastric motility examined by ultrasonography (US) after feeding 1) Gastric emptying rate (GER): GER = [(pyloric antral area (PA) at 1 minute after the end of feeding - PA at 15 minutes after the end of feeding) / PA at 1 minute after the end of feeding] * 100 (%) We measure the PA by positioning the US probe vertically simultaneously visualized the antrum, superior mesenteric artery, and abdominal aorta. 2) Antral contraction: Motility Index (MI) = Frequency * Amplitude Frequency = the number of contractions per 3 minutes Amplitude = [(PA at the time of relaxation - PA at the time of contraction) / PA at the time of relaxation] * 100 (%) We calculate MI in 2-5 minutes after the end of feeding.	—

Measure

Time frame

Gastric motility examined by ultrasonography (US) after feeding 1) Gastric emptying rate (GER): GER = [(pyloric antral area (PA) at 1 minute after the end of feeding - PA at 15 minutes after the end of feeding) / PA at 1 minute after the end of feeding] * 100 (%) We measure the PA by positioning the US probe vertically simultaneously visualized the antrum, superior mesenteric artery, and abdominal aorta. 2) Antral contraction: Motility Index (MI) = Frequency * Amplitude Frequency = the number of contractions per 3 minutes Amplitude = [(PA at the time of relaxation - PA at the time of contraction) / PA at the time of relaxation] * 100 (%) We calculate MI in 2-5 minutes after the end of feeding.

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Secondary

Measure	Time frame
Change in blood glucose levels (BG): The difference between BG before feeding and 30 minutes after the end of feeding	—

Countries

Japan

Contacts

Public ContactYusaku Kajihara

Fuyoukai Murakami Hospital Department of Gastroenterology

yukajihara-gi@umin.ac.jp+81-17-729-8888

Outcome results