42 babies out of originally 49 were finally included in a double - blind , randomized and placebo - controlled study . these underwent a routine check - up in the course of the preventive medical examinations in the 4 th to 6 th week of life and in the 14 th to 16 th week of life or at vaccination appointments in the doctor &# 39 ; s surgery . only healthy babies aged between 3 and 5 weeks were selected . 7 babies out of the original 49 were excluded : 4 on account of change of residence or non - compliance ( 2 in the verum group , 2 in the placebo group ), 2 on account of administration problems ( in the verum group ), 1 on account of alleged intolerance ( in the verum group ). hence n = 21 babies remained in each of the verum and placebo groups . there was no difference between the two groups as far as the basic demographic data of the mothers such as calendar age and gestational age , stimulants such as coffee , tea , alcohol and tobacco , and social and educational status were concerned . nor were there any differences between the groups in respect of the basic data of the babies such as weight at birth , size , circumference of the head at birth , gender distribution , incidence of malformation , course of labour and type of delivery . both groups showed good acceptance in handling and administering the test solutions . in both study groups , the babies were fed in a similar way and , proportionally , breast feeding , mother &# 39 ; s milk and hypoallergenic baby milk , mother &# 39 ; s milk and follow - on milk as follow - up to baby starting milk , exclusively baby starting milk and hypoallergenic baby milk , were divided in a similar way between the groups in view of the various times at which the examinations were carried out . it may be assumed that different nutritional concepts did not have any significant influence on the growth development of the babies in the present study . the physical examinations of the infants in the preliminary examination , the examination 5 weeks , and the examination 9 weeks after administration of the test substance , regarding the internal condition of heart , lung , abdominal organs , genital organs , ear , nose and throat , skin , skeleton , skull , nervous system and sense organs , showed no differences within the groups at the various times at which the examinations were conducted and no differences between the groups . the findings for the two groups over the cited measurement times in respect of the parameters relevant to the general state of health such as restlessness , flatulence , vomiting and bowel movement , were as follows : regarding bowel movement a slight reduction in complaints was noted over the entire measurement time ; there were no differences between the groups . as shown in fig1 , the two groups differ significantly in respect of the parameters restlessness and flatulence at the beginning of the study : in both respects , the verum group showed a significantly higher ( worse ) initial level . after start of administration of the test substance , a clearly different development occurred in the two groups : whereas the placebo group showed no change as regards restlessness , flatulence and vomiting over the measurement times , the values of the verum group improved to a highly significant extent . similarly , comparison between the groups after 5 weeks and 9 weeks , respectively , of administration of the test substance was highly significant : the babies of the verum group were evaluated significantly better for the parameters restlessness and flatulence . no difference in well - being in the subgroups formed with and without nicotine abuse and breast feeding in comparison with other forms of nutrition was found in terms of the parameters cited in connection with well - being . to evaluate the general state of health of the babies , the parents were asked to assess the respective parameter on a scale of 1 to 5 . the following significance was allocated to the numbers : 1 = none , 2 = little , 3 = average , 4 = severe , 5 = very severe . hip sonographies were carried out in accordance with the international criteria according to graf ( graf , r . “ kursus der hüftsonographie beim säugling ”, fischer - verlag , stuttgart , 1995 ). the hip sonography was carried out in a standardized manner in a positioning basin according to the guidelines of graf [ 11 , 11 ]. a 7 . 5 mhz linear scan ( ultramark ii +) was used as transducer ; in each case , two images were frozen and then printed on a video printer on a scale of 2 : 1 and the findings interpreted . in analogy with the criteria according to graf , alpha and beta angles and the following descriptive features were determined : bony formation , bony acetabular rim , roof of the acetabulum , cartilaginous roof , femoral head position and femoral head core . the hip type was thereby determined . the point in time of the sonographically determinable occurrence of ossification of the femoral head core was included as additional criterion for the maturing of the infant hip . the results of the hip sonography did not show any significant differences between the groups either for the alpha and beta angles ( see fig2 ) right and left or for the qualities of the morphological description , bony formation , bony acetabular rim , formation of the roof of the acetabulum and cartilaginous roof . a development of the hip type right and left into hip type ia was evident in both groups . in the classification according to hip types , there were not any significant differences , at any point in time , between the frequency of ia , ib and other hip types in the two study groups . differences did , however , occur between the groups with respect to both the number of proven femoral head cores and the point in time at which the femoral head cores formed . after 5 weeks of administration of the test substance , significantly more femoral head cores occurred in the verum group than in the placebo group . this effect also tends to remain after 9 weeks of administration of the test substance . numerically , this effect emerges more clearly when left and right sides are subjected to a joint evaluation . the level of significance of this difference lies at 6 %. similarly , the growth of the femoral head cores is significantly greater in the verum group than in the placebo group . after a further five weeks , the second physical examination including a hip sonography and the second investigation as to growth and general state of health were carried out at an appointment for vaccination . at the age of approximately 14 to 16 weeks , a physical examination and a hip sonography were then carried out on all patients , and a comprehensive anamnesis was recorded with respect to acceptance , side effects and development . the schematic structure of a matured hip joint is contained in sectional representation in fig2 with the definition of the above - mentioned alpha and beta angles . a ) a baby in which the femoral head core is formed and b ) a baby in which the femoral head core is not yet formed . finally , the data of table 1 are represented graphically in fig5 . the parents received as daily dietary supplement the numbered test substance in powder form , i . e ., gelatin hydrolysate of the gelitasol d type ( gelita deutschland gmbh , eberbach , germany ) or a placebo in the form of lactose monohydrate / aerosil . the parents were asked to ask to add once daily for 10 weeks a 1 g measuring spoonful to the baby food . as form of administration , it was suggested that the powder be dissolved in water or milk and be directly orally dispensed by means of a pipette simultaneously with a dose of the vitamin d prophylactic ( 500 iu . ( vitamin d - fluoretten )).
the use of collagen hydrolysate as dietary supplement to baby food , particularly to improve the general state of health in infants and bring about a reduction in restlessness , vomiting after food intake and flatulence , is disclosed .