In some nutritional studies, stool and gastrointestinal (GI) symptoms can be important outcome and safety parameters in both adult and infant studies. This data may then be used to assess if the study product has had any effect on stool frequency/consistency by comparing information collected at baseline with data collected during the study.
Stool assessments can be divided into two categories: (1) Bowel Movements and (2) Bowel Associated Symptoms.
Bowel Movement data is related to assessment of the bowel movement (e.g., frequency of the stool). Assessment of Stool relates to stool color and consistency and also laboratory measurements from feces samples (e.g., pH and bacterial composition).
Bowel Associated Symptoms represent the assessment of symptoms related to bowel movement (e.g., flatulence, abdominal distension, constipation).
Figure 5.1 Concept Map: Stool Assessments